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C O N F I D E N T I A L P a g e 1 | 155
Clinical Development
JNJ-7472179
EPO_INT3
Anonymisation Data Derivation Specification Document
Document Type Reference document Document Version Final
Date 24 Feb 2017
Property of Janssen
Confidential
May not be used, divulged, published or otherwise disclosed
without the consent of Janssen
Anonymisation Data Derivation Specification EPO_INT3
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Table of contents
Clinical Development.................................................................................................................. 1
1. Datasets ............................................................................................................................ 6
1.1. Specifications Introduction ............................................................................................... 6
1.2. Guidelines for Preparing Data............................................................................................ 6
1.3. Data Files ....................................................................................................................... 7
1.4. Data Domains ................................................................................................................. 8
1.4.1. Demographics - DEMO.................................................................................................. 8
1.4.2. Study Drug Administrator - ADMIN ................................................................................. 9
1.4.3. Adverse Events - ADVE.................................................................................................11
1.4.4. Bone marrow - BONEMARR ..........................................................................................13
1.4.5. Chemotherapy - CHEMO ..............................................................................................14
1.4.6. Serum Chemistry - CHEM_SI .........................................................................................16
1.4.7. Comment - CMNT .......................................................................................................18
1.4.8. Compdtl - COMPDTL ....................................................................................................19
1.4.9. Concomitant Therapy - CURM.......................................................................................21
1.4.10. Doseeval - DOSEEVAL ..................................................................................................23
1.4.11. Doseex - DOSEEX ........................................................................................................25
1.4.12. Effpval - EFFPVAL ........................................................................................................27
1.4.13. EPO Comment - EPCMNT .............................................................................................28
1.4.14. Epepo - EPEPO ............................................................................................................29
1.4.15. EPO Serum Levels - EPO ...............................................................................................30
1.4.16. Eposerum - EPOSERUM................................................................................................32
1.4.17. Evali3 - EVALI3 ............................................................................................................34
1.4.18. Hemai3 - HEMAI3........................................................................................................35
1.4.19. Hembi3 - HEMBI3........................................................................................................38
1.4.20. Hematology - HEM_SI ..................................................................................................41
1.4.21. History and Extent of Malignancy - HISTORY ...................................................................43
1.4.22. Harmone Therapy, Immunotherapy - HORRA ..................................................................45
1.4.23. Iron Supplementation - IRON ........................................................................................46
1.4.24. Ittpval - ITTPVAL .........................................................................................................47
1.4.25. Keyadve - KEYADVE .....................................................................................................48
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1.4.26. Keyadve1- KEYADVE1 ..................................................................................................51
1.4.27. Keyadve2 - KEYADVE2..................................................................................................54
1.4.28. Keyaeex - KEYAEEX ......................................................................................................57
1.4.29. Keycomp - KEYCOMP ...................................................................................................60
1.4.30. Keycomp1 - KEYCOMP1 ...............................................................................................62
1.4.31. Keycomp2 - KEYCOMP2 ...............................................................................................65
1.4.32. Keycurm - KEYCURM....................................................................................................67
1.4.33. Keydose - KEYDOSE .....................................................................................................71
1.4.34. Keylab1 - KEYLAB1.......................................................................................................73
1.4.35. Keysae - KEYSAE..........................................................................................................77
1.4.36. Keysae1 - KEYSAE1 ......................................................................................................80
1.4.37. Keysae2 - KAYSAE2 ......................................................................................................83
1.4.38. Keyvit1 - KEYVIT1 ........................................................................................................86
1.4.39. Keyfile_2 - KFILE_2 ......................................................................................................88
1.4.40. Labnorm - LABNORM...................................................................................................91
1.4.41. Labs - LABS.................................................................................................................92
1.4.42. Labs1 - LABS1 .............................................................................................................94
1.4.43. Medical History - MEDHIS.............................................................................................97
1.4.44. Normalsi - NORMALSI ..................................................................................................99
1.4.45. Otherlab - OTHERLAB ................................................................................................ 100
1.4.46. Performance Score - PERFOR ...................................................................................... 102
1.4.47. Initial Physical Examination - PHYSEX ........................................................................... 103
1.4.48. Initial Blood Pressure, Ht., Wt. - PPVI ........................................................................... 105
1.4.49. Profdose - PROFDOSE ................................................................................................ 107
1.4.50. Profeval - PROFEVAL.................................................................................................. 112
1.4.51. Profex - PROFEX ........................................................................................................ 117
1.4.52. Profile - PROFILE ....................................................................................................... 122
1.4.53. Protocol - PROTOCOL................................................................................................. 126
1.4.54. Pvalue - PVALUE ....................................................................................................... 128
1.4.55. EORTC QLQ-C30 - QLQC30 .......................................................................................... 129
1.4.56. Regi - REGI ............................................................................................................... 132
1.4.57. Smedai3 - SMEDAI3 ................................................................................................... 133
1.4.58. Smedbi3 - SMEDBI3 ................................................................................................... 135
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1.4.59. Smedci3 - SMEDCI3 ................................................................................................... 136
1.4.60. Smedci3b - SMEDCI3B................................................................................................ 138
1.4.61. Surgery - SURGERY .................................................................................................... 140
1.4.62. Respose to Chemotherapy - TERM............................................................................... 141
1.4.63. Tranai3 - TRANAI3 ..................................................................................................... 144
1.4.64. Tranbi3 - TRANBI3 ..................................................................................................... 146
1.4.65. Tranci3 - TRANCI3 ..................................................................................................... 148
1.4.66. Transfusion Information - TRANS_SI............................................................................. 151
1.4.67. Tve - TVE.................................................................................................................. 153
1.4.68. Urinalysis (Test Tape) - URIN_SI................................................................................... 154
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Status and Version Release Date Summary of Key Changes
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1. Datasets
1.1. Specifications Introduction This specification for each dataset will be in two parts
Dataset description
Variables within dataset
Part I: Dataset description
Dataset Name of dataset Creating Program The program that created the dataset Description Short description Unique Identifier Unique key Sorted by Sort key Notes Any useful notes
Part II: Variables within dataset
Variable SAS variable name
Type Character or Numeric Label SAS variable label Codes Codelist name
Comments Variable source derivation explanation if variable derived.
1.2. Guidelines for Preparing Data The data will be provided according to the De-identified/ Anonymisation data guidelines
standards with the following exceptions:
Subject initials will not be provided due to sensitivity of the data.
Investigator Information will not be provided.
Date of birth will not be provided, only age in years will be provided.
Age will be grouped to protect PII as per HIPAA rules (ages above 89 will be
assigned to 90+).
Subject and site/ center numbers will be assigned in a random manner so they
are not matching the subject and site/ center numbers that were used in the
actual trial.
Remove the free text verbatim terms.
Remove “Other” free text terms.
Drug Record Number will not be provided.
Drug Sequence Number will not be provided.
Accession Number will not be provided.
Vial and Bottle number will not be provided.
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Central Lab Specimen Label Number will not be provided.
Lab Identifier information will not be provided.
Vendor Panel Comments will not be provided.
Vendor Test Specific Comments will not be provided.
Lab Name information will not be provided.
All original dates relating to individuals subject will be removed. Instead a
Relative study day would be provided.
Completely missing variables those are not annotated in CRF will not be
included in the De-Identified datasets.
Partial date’s relative day cannot be calculated.
Datasets with zero observations will not be submitted
(ex.EPDEMO,NORMAL,SMEDBI3X)
Comment datasets (CMNT,EPCMNT) will be submitted with zero observation.
AGE is not present in DEMO dataset. So it will be added in DEMO from PROFILE
dataset.
PPROFILE dataset is meant for data reconciliation purpose. This datasets will be
removed.
Due to sensitive information INVN and JOURNAL datasets will be removed.
REF.DATE (Visit Date) will be used as Reference Date to derive relative days
(referred as REF. DATE in the document).
1.3. Data Files The EPO_INT3 Clinical Study Report (CSR) data should be used for converting to de-
identification.
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1.4. Data Domains
1.4.1. Demographics - DEMO
Dataset DEMO
Creating program demo.sas
Description Demographics
Unique identifier DPATNO
Sorted by DPATNO
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
missing values:
INIT,INO,VDATE,BIRTH,BIRTHF,VISITNO,EVENT_ID,SPECIFY
Below listed variable is not a part of raw dataset. It has been added to retain the age related information in the De-identified dataset:
AGE (Source: PROFILE Dataset)
AGEUNIT (Source: PROFILE Dataset)
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-Identity
Randomly assigned Patient Number for De-Identity
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Variable Type Label Codes Comments
DCENTER num Center Assigned for De-
Identity
Randomly assigned Center for De-Identity
DCOUNTRY num De-Identify Country Group element to protect PII.
VDATEF num Vdatef Collected at CRF.
SEX num Sex Collected at CRF.
RACE num Race Collected at CRF.
AGE char Age in Years If age is greater than 89 then group to '90+'
otherwise AGE=AGE. Grouping will be performed
based on HIPAA privacy rules.
AGEUNIT char Unit For Age Collected at CRF.
1.4.2. Study Drug Administrator - ADMIN
Dataset ADMIN
Creating program admin.sas
Description Study Drug Administrator
Unique identifier DPATNO,DY,EVENT_ID,VISITNO,WEEK,DOSENO
Sorted by DPATNO,DY,EVENT_ID,VISITNO,WEEK,DOSENO
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information:
INIT,INO,DATE
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Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
DOSENO num Dose Number Within Week (1,2,3) Collected at CRF.
DATEF num Datef Collected at CRF.
WEIGHT num Weight (Kg) Collected at CRF.
DOSE num Dose Given (U/Kg) Collected at CRF.
MEASU num Measu Collected at CRF.
ML num Ml Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
DY num Relative Medication Start Day If DATE and REF.DATE not missing then perform
below logic to calculate DY, If DATE less than
REF.DATE then (DATE - REF.DATE). Else if DATE is
greater than equal to REF.DATE then (DATE- REF.DATE) +1.
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1.4.3. Adverse Events - ADVE
Dataset ADVE
Creating program adve.sas
Description Adverse Events
Unique identifier DPATNO,ONSETDT,WHOCODE,EVENT_ID
Sorted by DPATNO,ONSETDT,WHOCODE,EVENT_ID
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
non significant elements:
INIT,INO,ADVSPE,DONSET,STOPD,ORIG_TXT,_USER_,_DATE_
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
ADVEXP num AE Occured Collected at CRF.
WHOCODE char Who Included Code Collected at CRF.
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Variable Type Label Codes Comments
BY_WHOCO char By_Whoco Collected at CRF.
ADVNOV char Advnov Collected at CRF.
DONSETF num Donsetf Collected at CRF.
ADVSEV num Advsev Collected at CRF.
ADVSER num Advser Collected at CRF.
ADVREL num Advrel Collected at CRF.
ADVTHER num Advther Collected at CRF.
ADVCON num Advcon Collected at CRF.
OUTCOME num Outcome Collected at CRF.
STOPDF num Stopdf Collected at CRF.
OBS num Obs Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
ONSETDY num Relative Onset Day of AE If DONSET and REF.DATE not missing then perform
below logic to calculate ONSETDY, If DONSET less
than REF.DATE then (DONSET - REF.DATE). Else if
DONSET is greater than equal to REF.DATE then (DONSET- REF.DATE) +1.
STOPDY num Relative Stop day If STOPD and REF.DATE not missing then perform
below logic to calculate STOPDY, If STOPD less
than REF.DATE then (STOPD - REF.DATE). Else if
STOPD is greater than equal to REF.DATE then (STOPD- REF.DATE) +1.
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Variable Type Label Codes Comments
ADVE_TM num Time Collected at CRF.
ADVE_DY num Relative Day If _DATE_ and REF.DATE not missing then perform
below logic to calculate ADVE_DY, If _DATE_ less
than REF.DATE then (_DATE_ - REF.DATE). Else if
_DATE_ is greater than equal to REF.DATE then (_DATE_- REF.DATE) +1.
1.4.4. Bone marrow - BONEMARR
Dataset BONEMARR
Creating program bonemarr.sas
Description Bonemarr
Unique identifier DPATNO,MMETAF
Sorted by DPATNO,MMETAF
Notes
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
MMETAF char Mmetaf Collected at CRF.
MMETA num Mmeta Collected at CRF.
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1.4.5. Chemotherapy - CHEMO
Dataset CHEMO
Creating program chemo.sas
Description Chemotherapy
Unique identifier DPATNO,VISITNO,CYCLES,DRUG,CSTARTDY,OBSNO
Sorted by DPATNO,VISITNO,CYCLES,DRUG,CSTARTDY,OBSNO
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
non significant elements:
INIT,INO,CSTART,CSTOP,ORIG_TXT,_USER_,_DATE_
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
CHEMO num Chemo Collected at CRF.
CYCLES num Cycles Collected at CRF.
DRUG char Drug Collected at CRF.
WHODRUG char Who*Drug*Code Collected at CRF.
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Variable Type Label Codes Comments
BY_WHODR char By_Whodr Collected at CRF.
CSTARTF num Cstartf Collected at CRF.
CSTOPF num Cstopf Collected at CRF.
ROUTE char Route Collected at CRF.
TDOSE char Tdose Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
CSTARTDY num Relative Cstart day If CSTART and REF.DATE not missing then perform
below logic to calculate CSTARTDY, If CSTART less
than REF.DATE then (CSTART - REF.DATE). Else if
CSTART is greater than equal to REF.DATE then (CSTART- REF.DATE) +1.
CSTOPDY num Relative Cstart Day If CSTOP and REF.DATE not missing then perform
below logic to calculate CSTOPDY, If CSTOP less
than REF.DATE then (CSTOP - REF.DATE). Else if
CSTOP is greater than equal to REF.DATE then (CSTOP- REF.DATE) +1.
CHEMO_TM num Time Collected at CRF.
CHEMO_DY num Relative Day If _DATE_ and REF.DATE not missing then perform
below logic to calculate CHEMO_DY, If _DATE_ less
than REF.DATE then (_DATE_ - REF.DATE). Else if
_DATE_ is greater than equal to REF.DATE then (_DATE_- REF.DATE) +1.
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1.4.6. Serum Chemistry - CHEM_SI
Dataset CHEM_SI
Creating program chem_si.sas
Description Serum Chemistry
Unique identifier DPATNO,VISITNO,VDY,IDY
Sorted by DPATNO,VISITNO,VDY,IDY
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information:
INIT,INO,VDATE,IDATE
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
VDATEF num Vdatef Collected at CRF.
IDATEF num Idatef Collected at CRF.
C201 num C201 Collected at CRF.
C202 num C202 Collected at CRF.
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Variable Type Label Codes Comments
C203 num C203 Collected at CRF.
C205 num C205 Collected at CRF.
C208 num C208 Collected at CRF.
C213 num C213 Collected at CRF.
C215 num C215 Collected at CRF.
C216 num C216 Collected at CRF.
C217 num C217 Collected at CRF.
C225 num C225 Collected at CRF.
C283 num C283 Collected at CRF.
C284 num C284 Collected at CRF.
C285 num C285 Collected at CRF.
C287 num C287 Collected at CRF.
C344 num C344 Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
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Variable Type Label Codes Comments
VDY num Relative Visit Day If VDATE and REF.DATE not missing then perform
below logic to calculate VDY, If VDATE less than
REF.DATE then (VDATE - REF.DATE). Else if VDATE
is greater than equal to REF.DATE then (VDATE- REF.DATE) +1.
IDY num Relative I Day If IDATE and REF.DATE not missing then perform
below logic to calculate IDY, If IDATE less than
REF.DATE then (IDATE - REF.DATE). Else if IDATE is
greater than equal to REF.DATE then (IDATE- REF.DATE) +1.
1.4.7. Comment - CMNT
Dataset CMNT
Creating program cmnt.sas
Description Comment
Unique identifier Not applicable
Sorted by Not applicable
Notes Comments data is sensitive data, contains free text information. Will be
submitted empty dataset.
Variable Type Label Codes Comments
OBSNO num Obsno Empty data will be submitted.
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Variable Type Label Codes Comments
STUDY char Study Empty data will be submitted.
DPATNO num Patient Number Assigned for De-
Identity
Empty data will be submitted.
CMTCODE char Cmtcode Empty data will be submitted.
VISITNO num Visit Number Empty data will be submitted.
WEEK num Study Week Empty data will be submitted.
QU num Qu Empty data will be submitted.
EVENT_ID char Event_Id Empty data will be submitted.
1.4.8. Compdtl - COMPDTL
Dataset COMPDTL
Creating program compdtl.sas
Description Compdtl
Unique identifier DPATNO,VDY,ADVCODE
Sorted by DPATNO,VDY,ADVCODE
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to non significant elements or due to missing values:
INIT,INO,VDATE,VISITNO,EVENT_ID,EVDATE,VERBATIM,ADVDESC
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Variable Type Label Codes Comments
ENTRYNO num Entryno Collected at CRF.
PNO char Protocol Number Collected at CRF.
DPATNO num Patient Number Assigned for De-Identity
Randomly assigned Patient Number for de-identity
VDATEF num Vdatef Collected at CRF.
TERM num Term Collected at CRF.
REASON num Reason Collected at CRF.
DIED num Died Collected at CRF.
PHASE num Phase Collected at CRF.
ADVCODE char Who Art Code Collected at CRF.
ACTION num Action Taken Collected at CRF.
VDY num Relative Visit day If VDATE and REF.DATE not missing then perform
below logic to calculate VDY, If VDATE less than
REF.DATE then (VDATE - REF.DATE). Else if VDATE
is greater than equal to REF.DATE then (VDATE- REF.DATE) +1.
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1.4.9. Concomitant Therapy - CURM
Dataset CURM
Creating program curm.sas
Description Concomitant Therapy
Unique identifier DPATNO,VISITNO,DRUG,TDOSE,CSTARTDY,CSTOPDY,OBSNO
Sorted by DPATNO,VISITNO,DRUG,TDOSE,CSTARTDY,CSTOPDY,OBSNO
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to non significant elements:
INIT,INO,CSTART,CSTOP,INDICAT,ORIG_TXT,_USER_,_DATE_
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
CONMED num Conmed Collected at CRF.
DRUG char Drug Collected at CRF.
WHODRUG char Who*Drug*Code Collected at CRF.
BY_WHODR char By_Whodr Collected at CRF.
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Variable Type Label Codes Comments
CSTARTF num Cstartf Collected at CRF.
CONT num Cont Collected at CRF.
CSTOPF num Cstopf Collected at CRF.
ROUTE char Route Collected at CRF.
TDOSE char Tdose Collected at CRF.
PRN num Prn Collected at CRF.
AE num AE Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
CSTARTDY num Relative Cstart Day If CSTART and REF.DATE not missing then perform
below logic to calculate CSTARTDY, If CSTART less
than REF.DATE then (CSTART - REF.DATE). Else if
CSTART is greater than equal to REF.DATE then (CSTART- REF.DATE) +1.
CSTOPDY num Relative Cstop Day If CSTOP and REF.DATE not missing then perform
below logic to calculate CSTOPDY, If CSTOP less
than REF.DATE then (CSTOP - REF.DATE). Else if
CSTOP is greater than equal to REF.DATE then (CSTOP- REF.DATE) +1.
CURM_TM num Time Collected at CRF.
CURM_DY num Relative Day If _DATE_ and REF.DATE not missing then perform
below logic to calculate CURM_DY, If _DATE_ less
than REF.DATE then (_DATE_ - REF.DATE). Else if
_DATE_ is greater than equal to REF.DATE then (_DATE_- REF.DATE) +1.
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1.4.10. Doseeval - DOSEEVAL
Dataset DOSEEVAL
Creating program doseeval.sas
Description Doseeval
Unique identifier DPATNO,STARTDY,STOPDY
Sorted by DPATNO,STARTDY,STOPDY
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to non significant elements or due to missing values:
INO,INVNAME,EPO,DATE,STARTDT,STOPDT,MEDSTRTM,MEDSTPTM,RTITLE1,RTITLE2,RTITLE3,REGIMEN
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-Identity
Randomly assigned Patient Number for de-identity
REGORDER num Order of Regimens Collected at CRF.
REGDESC char Treatment Collected at CRF.
EFFC num Is Patient Evaluable For Efficacy
Analys
Collected at CRF.
ITT num Is Patient Evaluable Fot Itt Analysis Collected at CRF.
TUMORTYP num Tumor Type Collected at CRF.
TUMORTYF char Decode For Ttype Collected at CRF.
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Variable Type Label Codes Comments
SAF num Is Patient Evaluable For Safety
Analysis
Collected at CRF.
EFF num Is Patient Evaluable For Efficacy
Analys
Collected at CRF.
EFFF char Decode For Eff (1=No, 2=Yes) Collected at CRF.
EFFCF char Decode For Eff (1=No, 2=Yes) Collected at CRF.
ITTF char Decode For Itt (1=No, 2=Yes) Collected at CRF.
SAFF char Decode For Saf (1=No, 2=Yes) Collected at CRF.
PNO char Protocol Number Collected at CRF.
PERIOD num Period For Initiation of Study Med Collected at CRF.
SEQUENCE num Treatment Sequence Collected at CRF.
XORDER num Cross-Over Order Collected at CRF.
THRPYDAY num Total Days On Therapy Collected at CRF.
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
STOPDY num Relative Medication Stop Day If STOPDT and REF.DATE not missing then perform
below logic to calculate STOPDY, If STOPDT less
than REF.DATE then (STOPDT - REF.DATE). Else if
STOPDT is greater than equal to REF.DATE then (STOPDT- REF.DATE) +1.
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1.4.11. Doseex - DOSEEX
Dataset DOSEEX
Creating program doseex.sas
Description Doseex
Unique identifier DPATNO,STARTDY,STOPDY
Sorted by DPATNO,STARTDY,STOPDY
Notes Below listed variables will be dropped from dataset due to non significant
elements or due to repetition of the information or due to missing values:
RTITLE2,EPO,DATE,STARTDT,STOPDT,MEDSTRTM,MEDSTPTM,RTITLE1,
RTITLE3,REGIMEN
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
REGORDER num Order of Regimens Collected at CRF.
PNO char Protocol Number Collected at CRF.
PERIOD num Period For Initiation of Study Med Collected at CRF.
SEQUENCE num Treatment Sequence Collected at CRF.
XORDER num Cross-Over Order Collected at CRF.
THRPYDAY num Total Days On Therapy Collected at CRF.
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Variable Type Label Codes Comments
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
STOPDY num Relative Medication Stop Day If STOPDT and REF.DATE not missing then perform
below logic to calculate STOPDY, If STOPDT less
than REF.DATE then (STOPDT - REF.DATE). Else if
STOPDT is greater than equal to REF.DATE then (STOPDT- REF.DATE) +1.
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1.4.12. Effpval - EFFPVAL
Dataset EFFPVAL
Creating program effpval.sas
Description Effpval
Unique identifier PVAL
Sorted by PVAL
Notes
Variable Type Label Codes Comments
PVAL num Pr>Chi Collected at CRF.
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1.4.13. EPO Comment - EPCMNT
Dataset EPCMNT
Creating program epcmnt.sas
Description EPO Comment
Unique identifier Not applicable
Sorted by Not applicable
Notes Comments data is sensitive data, contains free text information. Will be
submitted empty dataset.
Variable Type Label Codes Comments
OBSNO num Obsno Empty data will be submitted.
STUDY char Study Empty data will be submitted.
DPATNO num Patient Number Assigned for De-
Identity
Empty data will be submitted.
CMTCODE char Cmtcode Empty data will be submitted.
SAMDY num Relative Sample Day Empty data will be submitted.
SAMDF num Samdf Empty data will be submitted.
VISITNO num Visit Number Empty data will be submitted.
EVENT_ID char Event_Id Empty data will be submitted.
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1.4.14. Epepo - EPEPO
Dataset EPEPO
Creating program epepo.sas
Description Epepo
Unique identifier DPATNO,EPODY,EPOVAL,OBSNO
Sorted by DPATNO,EPODY,EPOVAL,OBSNO
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information:
INIT,EPOD
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
FORCEN num Forcen Collected at CRF.
EPODF num Epodf Collected at CRF.
EPOVAL num Epoval Collected at CRF.
VISITNO num Visit Number Collected at CRF.
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Variable Type Label Codes Comments
EVENT_ID char Event_Id Collected at CRF.
EPODY num Relative Epod Day If EPOD and REF.DATE not missing then perform
below logic to calculate EPODY, If EPOD less than
REF.DATE then (EPOD - REF.DATE). Else if EPOD is
greater than equal to REF.DATE then (EPOD- REF.DATE) +1.
1.4.15. EPO Serum Levels - EPO
Dataset EPO
Creating program epo.sas
Description EPO Serum Levels
Unique identifier DPATNO,VISITNO,EPODY,OBSNO
Sorted by DPATNO,VISITNO,EPODY,OBSNO
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information:
INIT,INO,EPO
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
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Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
EPOF num Epof Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
EPODY num Relative Epo Day If EPO and REF.DATE not missing then perform
below logic to calculate EPODY, If EPO less than
REF.DATE then (EPO - REF.DATE). Else if EPO is
greater than equal to REF.DATE then (EPO-
REF.DATE) +1.
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1.4.16. Eposerum - EPOSERUM
Dataset EPOSERUM
Creating program eposerum.sas
Description Eposerum
Unique identifier DPATNO,VISITNO,EPODY,STARTDY,EPOVAL
Sorted by DPATNO,VISITNO,EPODY,STARTDY,EPOVAL
Notes Below listed variables will be dropped from dataset due to repetition of the
information:
EPO,EPOD,STARTDT
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
EPOF num Date Flag Collected at CRF.
EPODF num Date Flag Collected at CRF.
EPOVAL num Epo Serum Level Result Collected at CRF.
EPO_DY num Relative Day Recorded When
Sample Taken
If EPO and REF.DATE not missing then perform
below logic to calculate EPO_DY, If EPO less than
REF.DATE then (EPO - REF.DATE). Else if EPO is
greater than equal to REF.DATE then (EPO- REF.DATE) +1.
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Variable Type Label Codes Comments
EPODY num Relative Day Recorded With
Sample Results
If EPOD and REF.DATE not missing then perform
below logic to calculate EPODY, If EPOD less than
REF.DATE then (EPOD - REF.DATE). Else if EPOD is
greater than equal to REF.DATE then (EPOD- REF.DATE) +1.
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
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1.4.17. Evali3 - EVALI3
Dataset EVALI3
Creating program evali3.sas
Description Evali3
Unique identifier DPATNO,REGDESC
Sorted by DPATNO,REGDESC
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines:
INO,INVNAME
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
REGORDER num Order of Regimens Collected at CRF.
REGDESC char Treatment Collected at CRF.
EFFC num Is Patient Evaluable For Efficacy
Analys
Collected at CRF.
ITT num Is Patient Evaluable Fot Itt Analysis Collected at CRF.
TUMORTYP num Tumor Type Collected at CRF.
TUMORTYF char Decode For Ttype Collected at CRF.
SAF num Is Patient Evaluable For Safety
Analysis
Collected at CRF.
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Variable Type Label Codes Comments
EFF num Is Patient Evaluable For Efficacy
Analys
Collected at CRF.
EFFF char Decode For Eff (1=No, 2=Yes) Collected at CRF.
EFFCF char Decode For Eff (1=No, 2=Yes) Collected at CRF.
ITTF char Decode For Itt (1=No, 2=Yes) Collected at CRF.
SAFF char Decode For Saf (1=No, 2=Yes) Collected at CRF.
1.4.18. Hemai3 - HEMAI3
Dataset HEMAI3
Creating program hemai3.sas
Description Hemai3
Unique identifier DPATNO,VISITNO,STARTDY,LABDY,CRFWEEK
Sorted by DPATNO,VISITNO,STARTDY,LABDY,CRFWEEK
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information:
DATE,STARTDT,DBENDDT,INVNAME,LABDATE,SAMPDT
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
REGORDER num Order of Regimens Collected at CRF.
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Variable Type Label Codes Comments
REGDESC char Treatment Collected at CRF.
VISITNO num Visit Number Collected at CRF.
CRFWEEK num Study Week From Data Collected at CRF.
HGB num Hemoglobin Value Collected at CRF.
NEUTR num Neutrophil Value (%) Collected at CRF.
RCT num Reticulocyte Collected at CRF.
ABSNEUT num Absolute Neutrophil Value Collected at CRF.
TRANRL14 num Are Labs Rela To Trans <= 14 Days Collected at CRF.
TRANRL28 num Are Labs Rela To Trans <= 28 Days Collected at CRF.
TRNRL14F char Decode For Tranrl14 (1=No, 2=Yes) Collected at CRF.
TRNRL28F char Decode For Tranrl28 (1=No, 2=Yes) Collected at CRF.
WEEK num Derived Week Collected at CRF.
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
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Variable Type Label Codes Comments
DBENDDY num Relative Last Day of Double-Blind
Phase
If DBENDDT and REF.DATE not missing then
perform below logic to calculate DBENDDY, If
DBENDDT less than REF.DATE then (DBENDDT -
REF.DATE). Else if DBENDDT is greater than equal to REF.DATE then (DBENDDT- REF.DATE) +1.
LABDY num Relative Sample Day If LABDATE and REF.DATE not missing then
perform below logic to calculate LABDY, If
LABDATE less than REF.DATE then (LABDATE -
REF.DATE). Else if LABDATE is greater than equal to REF.DATE then (LABDATE- REF.DATE) +1.
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1.4.19. Hembi3 - HEMBI3
Dataset HEMBI3
Creating program hembi3.sas
Description Hembi3
Unique identifier DPATNO
Sorted by DPATNO
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information:
CORRDT,RESPDT,MAXHBDT,INVNAME
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
BHGB num Baseline Hemoglobin Value Collected at CRF.
FHGB num Last Hemoglobin Value Collected at CRF.
CHHGB num Change of Hgb From Base To Last
Value
Collected at CRF.
BRCT num Baseline Reticulocyte Value Collected at CRF.
FRCT num Last Reticulocyte Value Collected at CRF.
CHRCT num Change of Rct From Base To Last
Value
Collected at CRF.
CORRHB num Hgb Value At Corrday Collected at CRF.
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Variable Type Label Codes Comments
CORRECT num Was Patient A Corrector Collected at CRF.
RESPHB num Hgb Value At Respday Collected at CRF.
RESPOND num Did Patient Respond To Therapy Collected at CRF.
MAXHB num Max. Hgb Value During Db Phase Collected at CRF.
BEPO num Baseline Epo Serum Value Collected at CRF.
BNEUTR num Baseline Neutrophil Value (%) Collected at CRF.
BABSNEUT num Absolute Baseline Neutrophil Value Collected at CRF.
REGORDER num Order of Regimens Collected at CRF.
REGDESC char Treatment Collected at CRF.
CORRECTF char Decode For Correct (1=No, 2=Yes) Collected at CRF.
RESPONDF char Decode For Respond (1=No, 2=Yes) Collected at CRF.
CORRDAY num Day of Correction Collected at CRF.
RESPDAY num Day of Response Collected at CRF.
MAXHBDAY num Day of Maximum Hgb Value Collected at CRF.
FHGBDAY num Day of Last Hemoglobin Collected at CRF.
CORRDY num Relative Day of Correction If CORRDT and REF.DATE not missing then perform
below logic to calculate CORRDY, If CORRDT less
than REF.DATE then (CORRDT - REF.DATE). Else if
CORRDT is greater than equal to REF.DATE then (CORRDT- REF.DATE) +1.
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Variable Type Label Codes Comments
RESPDY num Relative Day of Response If RESPDT and REF.DATE not missing then perform
below logic to calculate RESPDY, If RESPDT less
than REF.DATE then (RESPDT - REF.DATE). Else if
RESPDT is greater than equal to REF.DATE then (RESPDT- REF.DATE) +1.
MAXHBDY num Relative Day of Maximum Hgb
Value
If MAXHBDT and REF.DATE not missing then
perform below logic to calculate MAXHBDY, If
MAXHBDT less than REF.DATE then (MAXHBDT -
REF.DATE). Else if MAXHBDT is greater than equal to REF.DATE then (MAXHBDT- REF.DATE) +1.
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1.4.20. Hematology - HEM_SI
Dataset HEM_SI
Creating program hem_si.sas
Description Hematology
Unique identifier DPATNO,VISITNO,VDY,OBSNO
Sorted by DPATNO,VISITNO,VDY,OBSNO
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information: INIT,INO,VDATE
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
VDATEF num Vdatef Collected at CRF.
CH116 char Ch116 Collected at CRF.
H132 num H132 Collected at CRF.
H108 num H108 Collected at CRF.
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Variable Type Label Codes Comments
H111 num H111 Collected at CRF.
H103 num H103 Collected at CRF.
H114 num H114 Collected at CRF.
H117 num H117 Collected at CRF.
H112 num H112 Collected at CRF.
H116 num H116 Collected at CRF.
H113 num H113 Collected at CRF.
H101 num H101 Collected at CRF.
H102 num H102 Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
VDY num Relative Visit Day If VDATE and REF.DATE not missing then perform
below logic to calculate VDY, If VDATE less than
REF.DATE then (VDATE - REF.DATE). Else if VDATE
is greater than equal to REF.DATE then (VDATE- REF.DATE) +1.
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1.4.21. History and Extent of Malignancy - HISTORY
Dataset HISTORY
Creating program history.sas
Description History and Extent of Malignancy
Unique identifier DPATNO
Sorted by DPATNO
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
missing values: INIT,INO,VDATE,DIAG,DIAGNOS,RECENT,VISITNO,EVENT_ID
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VDATEF num Vdatef Collected at CRF.
DIAGF num Diagf Collected at CRF.
MALIGN num Malign Collected at CRF.
SITE char Site Collected at CRF.
TNM char Tnm Collected at CRF.
C_TUMOR char C_Tumor Collected at CRF.
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Variable Type Label Codes Comments
METAST char Metast Collected at CRF.
VDY num Relative Visit Day If VDATE and REF.DATE not missing then perform
below logic to calculate VDY, If VDATE less than
REF.DATE then (VDATE - REF.DATE). Else if VDATE
is greater than equal to REF.DATE then (VDATE- REF.DATE) +1.
DIAG_DY num Relative Diagnosis Day If DIAG and REF.DATE not missing then perform
below logic to calculate DIAG_DY, If DIAG less than
REF.DATE then (DIAG - REF.DATE). Else if DIAG is
greater than equal to REF.DATE then (DIAG- REF.DATE) +1.
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1.4.22. Harmone Therapy, Immunotherapy - HORRA
Dataset HORRA
Creating program horra.sas
Description Harmone Therapy, Immunotherapy
Unique identifier DPATNO,LDY,DRUG,THERAPY,TYPE
Sorted by DPATNO,LDY,DRUG,THERAPY,TYPE
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
non significant elements or due to missing values: INIT,INO,WHODRUG,INDICAT,LDATE
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
TYPE num Type Collected at CRF.
THERAPY num Therapy Collected at CRF.
DRUG char Drug Collected at CRF.
LDATEF num Ldatef Collected at CRF.
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Variable Type Label Codes Comments
CONT num Cont Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
LDY num L Day If LDATE and REF.DATE not missing then perform
below logic to calculate LDY, If LDATE less than
REF.DATE then (LDATE - REF.DATE). Else if LDATE is
greater than equal to REF.DATE then (LDATE- REF.DATE) +1.
1.4.23. Iron Supplementation - IRON
Dataset IRON
Creating program iron.sas
Description Iron Supplementation
Unique identifier DPATNO,VISITNO,WEEK
Sorted by DPATNO,VISITNO,WEEK
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines:
INIT,INO,NAME
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
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Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
ADM char Administration Collected at CRF.
TDOSE char Total Weekly Dose Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
1.4.24. Ittpval - ITTPVAL
Dataset ITTPVAL
Creating program ittpval.sas
Description Ittpval
Unique identifier PVAL
Sorted by PVAL
Notes
Variable Type Label Codes Comments
PVAL num Pr>Chi Collected at CRF.
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1.4.25. Keyadve - KEYADVE
Dataset KEYADVE
Creating program keyadve.sas
Description Keyadve
Unique identifier DPATNO,VISITNO,ONSETDY,STARTDY,DBENDDY,BODYSYS
Sorted by DPATNO,VISITNO,ONSETDY,STARTDY,DBENDDY,BODYSYS
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
non significant elements or due to missing values:
VERBATIM,DONSET,STOPD,STOPDT,ONSETDT,ADVDESC,INO,DATE,STARTDT,DBENDDT,INVNAME,SURN,FORE,REGDAY,STOPTIME,TONSET
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Week Collected at CRF.
ADVEXP num AE Occured Collected at CRF.
ADVCODE char Who Art Code Collected at CRF.
SEVERITY num Severity Collected at CRF.
SERIOUS num Serious AE Collected at CRF.
ACTION num Action Taken Collected at CRF.
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Variable Type Label Codes Comments
CONCOM num Com Med Given Collected at CRF.
OUTCOME num Outcome of AE Collected at CRF.
STOPDF num Stop Date of AE Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
PNO char Protocol Number Collected at CRF.
DRUGREL num Relationship To Study Drug Collected at CRF.
VISIT char Visit Collected at CRF.
SEXAE char Sex Specific AE Collected at CRF.
BODYSYS char Body System Collected at CRF.
PREF_TRM char Perferred Term Collected at CRF.
OL num Was Patient In Open-Label Study Collected at CRF.
TRTMENTF char Treatment Collected at CRF.
TRTMENT num Treatment Code Collected at CRF.
PERIOD num Medication Period Collected at CRF.
OUTCOMEF char Outcome of AE Collected at CRF.
CONCOMF char Com Med Given Collected at CRF.
ACTIONF char Action Taken Collected at CRF.
DRUGRELF char Relationship To Study Drug Collected at CRF.
SEVERITF char Severity Collected at CRF.
SERIOUSF char Serious AE Collected at CRF.
ADVEXPF char AE Occured Collected at CRF.
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Variable Type Label Codes Comments
DURDAY num Duration of AE Collected at CRF.
STUDYDAY num Study Day Collected at CRF.
PHASE num Study Phase Collected at CRF.
ONSETDY num Relative Onset Day of AE If DONSET and REF.DATE not missing then perform
below logic to calculate ONSETDY, If DONSET less
than REF.DATE then (DONSET - REF.DATE). Else if
DONSET is greater than equal to REF.DATE then (DONSET- REF.DATE) +1.
STOPDY num Relative Stop Day of AE If STOPD and REF.DATE not missing then perform
below logic to calculate STOPDY, If STOPD less
than REF.DATE then (STOPD - REF.DATE). Else if
STOPD is greater than equal to REF.DATE then (STOPD- REF.DATE) +1.
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
DBENDDY num Relative Last Day of Double-Blind
Phase
If DBENDDT and REF.DATE not missing then
perform below logic to calculate DBENDDY, If
DBENDDT less than REF.DATE then (DBENDDT -
REF.DATE). Else if DBENDDT is greater than equal to REF.DATE then (DBENDDT- REF.DATE) +1.
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1.4.26. Keyadve1- KEYADVE1
Dataset KEYADVE1
Creating program keyadve1.sas
Description Keyadve1
Unique identifier DPATNO,VISITNO,ONSETDY,STARTDY,DBENDDY,BODYSYS
Sorted by DPATNO,VISITNO,ONSETDY,STARTDY,DBENDDY,BODYSYS
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
non significant elements or due to missing values:
VERBATIM,DONSET,STOPD,STOPDT,ONSETDT,ADVDESC,INO,DATE,STARTDT,DBENDDT,INVNAME,SURN,FORE,REGDAY,STOPTIME,TONSET
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Week Collected at CRF.
ADVEXP num AE Occured Collected at CRF.
ADVCODE char Who Art Code Collected at CRF.
SEVERITY num Severity Collected at CRF.
SERIOUS num Serious AE Collected at CRF.
ACTION num Action Taken Collected at CRF.
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Variable Type Label Codes Comments
CONCOM num Com Med Given Collected at CRF.
OUTCOME num Outcome of AE Collected at CRF.
STOPDF num Stop Date of AE Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
PNO char Protocol Number Collected at CRF.
DRUGREL num Relationship To Study Drug Collected at CRF.
VISIT char Visit Collected at CRF.
SEXAE char Sex Specific AE Collected at CRF.
BODYSYS char Body System Collected at CRF.
PREF_TRM char Perferred Term Collected at CRF.
OL num Was Patient In Open-Label Study Collected at CRF.
TRTMENTF char Treatment Collected at CRF.
TRTMENT num Treatment Code Collected at CRF.
PERIOD num Medication Period Collected at CRF.
OUTCOMEF char Outcome of AE Collected at CRF.
CONCOMF char Com Med Given Collected at CRF.
ACTIONF char Action Taken Collected at CRF.
DRUGRELF char Relationship To Study Drug Collected at CRF.
SEVERITF char Severity Collected at CRF.
SERIOUSF char Serious AE Collected at CRF.
ADVEXPF char Ae Occured Collected at CRF.
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Variable Type Label Codes Comments
DURDAY num Duration of AE Collected at CRF.
STUDYDAY num Study Day Collected at CRF.
PHASE num Study Phase Collected at CRF.
ONSETDY num Relative Onset Day of AE If DONSET and REF.DATE not missing then perform
below logic to calculate ONSETDY, If DONSET less
than REF.DATE then (DONSET - REF.DATE). Else if
DONSET is greater than equal to REF.DATE then (DONSET- REF.DATE) +1.
STOPDY num Relative Stop Day of AE If STOPDT and REF.DATE not missing then perform
below logic to calculate STOPDY, If STOPDT less
than REF.DATE then (STOPDT - REF.DATE). Else if
STOPDT is greater than equal to REF.DATE then (STOPDT- REF.DATE) +1.
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
DBENDDY num Relative Last Day of Double-Blind
Phase
If DBENDDT and REF.DATE not missing then
perform below logic to calculate DBENDDY, If
DBENDDT less than REF.DATE then (DBENDDT -
REF.DATE). Else if DBENDDT is greater than equal to REF.DATE then (DBENDDT- REF.DATE) +1.
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1.4.27. Keyadve2 - KEYADVE2
Dataset KEYADVE2
Creating program keyadve2.sas
Description Keyadve2
Unique identifier DPATNO,VISITNO,ONSETDY,STARTDY,DBENDDY,BODYSYS
Sorted by DPATNO,VISITNO,ONSETDY,STARTDY,DBENDDY,BODYSYS
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
non significant elements or due to missing values:
VERBATIM,DONSET,STOPD,STOPDT,ONSETDT,ADVDESC,INO,DATE,STARTDT,DBENDDT,INVNAME,SURN,FORE,REGDAY,STOPTIME,TONSET
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Week Collected at CRF.
ADVEXP num AE Occured Collected at CRF.
ADVCODE char Who Art Code Collected at CRF.
SEVERITY num Severity Collected at CRF.
SERIOUS num Serious AE Collected at CRF.
ACTION num Action Taken Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 55 | 155
Variable Type Label Codes Comments
CONCOM num Com Med Given Collected at CRF.
OUTCOME num Outcome of AE Collected at CRF.
STOPDF num Stop Date of AE Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
PNO char Protocol Number Collected at CRF.
DRUGREL num Relationship To Study Drug Collected at CRF.
VISIT char Visit Collected at CRF.
SEXAE char Sex Specific AE Collected at CRF.
BODYSYS char Body System Collected at CRF.
PREF_TRM char Perferred Term Collected at CRF.
OL num Was Patient In Open-Label Study Collected at CRF.
TRTMENTF char Treatment Collected at CRF.
TRTMENT num Treatment Code Collected at CRF.
PERIOD num Medication Period Collected at CRF.
OUTCOMEF char Outcome of AE Collected at CRF.
CONCOMF char Com Med Given Collected at CRF.
ACTIONF char Action Taken Collected at CRF.
DRUGRELF char Relationship To Study Drug Collected at CRF.
SEVERITF char Severity Collected at CRF.
SERIOUSF char Serious AE Collected at CRF.
ADVEXPF char AE Occured Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
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Variable Type Label Codes Comments
DURDAY num Duration of AE Collected at CRF.
STUDYDAY num Study Day Collected at CRF.
PHASE num Study Phase Collected at CRF.
ONSETDY num Relative Onset Day of AE If DONSET and REF.DATE not missing then perform
below logic to calculate ONSETDY, If DONSET less
than REF.DATE then (DONSET - REF.DATE). Else if
DONSET is greater than equal to REF.DATE then (DONSET- REF.DATE) +1.
STOPDY num Relative Stop Day of AE If STOPD and REF.DATE not missing then perform
below logic to calculate STOPDY, If STOPD less
than REF.DATE then (STOPD - REF.DATE). Else if
STOPD is greater than equal to REF.DATE then (STOPD- REF.DATE) +1.
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
DBENDDY num Relative Last Day of Double-Blind
Phase
If DBENDDT and REF.DATE not missing then
perform below logic to calculate DBENDDY, If
DBENDDT less than REF.DATE then (DBENDDT -
REF.DATE). Else if DBENDDT is greater than equal to REF.DATE then (DBENDDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 57 | 155
1.4.28. Keyaeex - KEYAEEX
Dataset KEYAEEX
Creating program keyaeex.sas
Description Keyaeex
Unique identifier DPATNO,VISITNO,ONSETDY,STOPDY,BODYSYS,SEVERITY
Sorted by DPATNO,VISITNO,ONSETDY,STOPDY,BODYSYS,SEVERITY
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
non significant elements or due to missing values:
VERBATIM,DONSET,STOPD,STOPDT,ONSETDT,ADVDESC,INO,DATE,STARTDT,DBENDDT,INVNAME,SURN,FORE,REGDAY,STOPTIME,TONSET
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Week Collected at CRF.
ADVEXP num AE Occured Collected at CRF.
ADVCODE char Who Art Code Collected at CRF.
SEVERITY num Severity Collected at CRF.
SERIOUS num Serious AE Collected at CRF.
ACTION num Action Taken Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 58 | 155
Variable Type Label Codes Comments
CONCOM num Com Med Given Collected at CRF.
OUTCOME num Outcome of AE Collected at CRF.
STOPDF num Stop Date of AE Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
PNO char Protocol Number Collected at CRF.
DRUGREL num Relationship To Study Drug Collected at CRF.
VISIT char Visit Collected at CRF.
SEXAE char Sex Specific AE Collected at CRF.
BODYSYS char Body System Collected at CRF.
PREF_TRM char Perferred Term Collected at CRF.
OL num Was Patient In Open-Label Study Collected at CRF.
TRTMENTF char Treatment Collected at CRF.
TRTMENT num Treatment Code Collected at CRF.
PERIOD num Medication Period Collected at CRF.
OUTCOMEF char Outcome of AE Collected at CRF.
CONCOMF char Com Med Given Collected at CRF.
ACTIONF char Action Taken Collected at CRF.
DRUGRELF char Relationship To Study Drug Collected at CRF.
SEVERITF char Severity Collected at CRF.
SERIOUSF char Serious AE Collected at CRF.
ADVEXPF char AE Occured Collected at CRF.
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Variable Type Label Codes Comments
DURDAY num Duration of AE Collected at CRF.
STUDYDAY num Study Day Collected at CRF.
PHASE num Study Phase Collected at CRF.
REGORDER num Order of Regimens Collected at CRF.
ONSETDY num Relative Onset Day of AE If DONSET and REF.DATE not missing then perform
below logic to calculate ONSETDY, If DONSET less
than REF.DATE then (DONSET - REF.DATE). Else if
DONSET is greater than equal to REF.DATE then (DONSET- REF.DATE) +1.
STOPDY num Relative Stop Day of AE If STOPDT and REF.DATE not missing then perform
below logic to calculate STOPDY, If STOPDT less
than REF.DATE then (STOPDT - REF.DATE). Else if
STOPDT is greater than equal to REF.DATE then (STOPDT- REF.DATE) +1.
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to
REF.DATE then (STARTDT- REF.DATE) +1.
DBENDDY num Relative Last Day of Double-Blind
Phase
If DBENDDT and REF.DATE not missing then
perform below logic to calculate DBENDDY, If
DBENDDT less than REF.DATE then (DBENDDT -
REF.DATE). Else if DBENDDT is greater than equal to REF.DATE then (DBENDDT- REF.DATE) +1.
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1.4.29. Keycomp - KEYCOMP
Dataset KEYCOMP
Creating program keycomp.sas
Description Keycomp
Unique identifier DPATNO,STATUSDY,BODYSYS
Sorted by DPATNO,STATUSDY,BODYSYS
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
non significant elements or due to missing values:
INO,STATUSDT,DEATHDT,INVNAME,SURN,FORE,VERBATIM,ADVDESC, REGDAY
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
STATUS num Completion Status Collected at CRF.
REASON num Discontinuation Reason Collected at CRF.
OL num Was Patient In Open-Label Study Collected at CRF.
COMPDAYS num Number of Days To Study
Completion
Collected at CRF.
ADVEXP num AE Occured Collected at CRF.
ADVCODE char Who Art Code Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
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Variable Type Label Codes Comments
SEVERITY num Severity Collected at CRF.
SERIOUS num Serious AE Collected at CRF.
ACTION num Action Taken Collected at CRF.
PNO char Protocol Number Collected at CRF.
DRUGREL num Relationship To Study Drug Collected at CRF.
SEXAE char Sex Specific AE Collected at CRF.
BODYSYS char Body System Collected at CRF.
PREF_TRM char Perferred Term Collected at CRF.
PERIOD num Medication Period Collected at CRF.
ACTIONF char Action Taken Collected at CRF.
DRUGRELF char Relationship To Study Drug Collected at CRF.
SEVERITF char Severity Collected at CRF.
SERIOUSF char Serious AE Collected at CRF.
DURDAY num Duration of AE Collected at CRF.
STUDYDAY num Study Day Collected at CRF.
STATUSDY num Relative Completion Status Day If STATUSDT and REF.DATE not missing then
perform below logic to calculate STATUSDY, If
STATUSDT less than REF.DATE then (STATUSDT -
REF.DATE). Else if STATUSDT is greater than equal to REF.DATE then (STATUSDT- REF.DATE) +1.
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Variable Type Label Codes Comments
DEATHDY num Relative Day of Death If DEATHDT and REF.DATE not missing then
perform below logic to calculate DEATHDY, If
DEATHDT less than REF.DATE then (DEATHDT -
REF.DATE). Else if DEATHDT is greater than equal to REF.DATE then (DEATHDT- REF.DATE) +1.
1.4.30. Keycomp1 - KEYCOMP1
Dataset KEYCOMP1
Creating program keycomp1.sas
Description Keycomp1
Unique identifier DPATNO,STATUSDY, BODYSYS
Sorted by DPATNO,STATUSDY, BODYSYS
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
non significant elements or due to missing values:
INO,STATUSDT,DEATHDT,INVNAME,SURN,FORE,VERBATIM,ADVDESC, REGDAY
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
STATUS num Completion Status Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
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Variable Type Label Codes Comments
REASON num Discontinuation Reason Collected at CRF.
OL num Was Patient In Open-Label Study Collected at CRF.
COMPDAYS num Number of Days To Study Completion
Collected at CRF.
ADVEXP num AE Occured Collected at CRF.
ADVCODE char Who Art Code Collected at CRF.
SEVERITY num Severity Collected at CRF.
SERIOUS num Serious AE Collected at CRF.
ACTION num Action Taken Collected at CRF.
PNO char Protocol Number Collected at CRF.
DRUGREL num Relationship To Study Drug Collected at CRF.
SEXAE char Sex Specific AE Collected at CRF.
BODYSYS char Body System Collected at CRF.
PREF_TRM char Perferred Term Collected at CRF.
PERIOD num Medication Period Collected at CRF.
ACTIONF char Action Taken Collected at CRF.
DRUGRELF char Relationship To Study Drug Collected at CRF.
SEVERITF char Severity Collected at CRF.
SERIOUSF char Serious AE Collected at CRF.
DURDAY num Duration of AE Collected at CRF.
STUDYDAY num Study Day Collected at CRF.
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Variable Type Label Codes Comments
STATUSDY num Relative Completion Status Day If STATUSDT and REF.DATE not missing then
perform below logic to calculate STATUSDY, If
STATUSDT less than REF.DATE then (STATUSDT -
REF.DATE). Else if STATUSDT is greater than equal to REF.DATE then (STATUSDT- REF.DATE) +1.
DEATHDY num Relative Day of Death If DEATHDT and REF.DATE not missing then
perform below logic to calculate DEATHDY, If
DEATHDT less than REF.DATE then (DEATHDT -
REF.DATE). Else if DEATHDT is greater than equal to REF.DATE then (DEATHDT- REF.DATE) +1.
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1.4.31. Keycomp2 - KEYCOMP2
Dataset KEYCOMP2
Creating program keycomp2.sas
Description Keycomp2
Unique identifier DPATNO,STATUSDY,BODYSYS
Sorted by DPATNO,STATUSDY,BODYSYS
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
non significant elements or due to missing values:
INO,STATUSDT,DEATHDT,INVNAME,SURN,FORE,VERBATIM,ADVDESC, REGDAY
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
STATUS num Completion Status Collected at CRF.
REASON num Discontinuation Reason Collected at CRF.
OL num Was Patient In Open-Label Study Collected at CRF.
COMPDAYS num Number of Days To Study
Completion
Collected at CRF.
ADVEXP num AE Occured Collected at CRF.
ADVCODE char Who Art Code Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 66 | 155
SEVERITY num Severity Collected at CRF.
SERIOUS num Serious AE Collected at CRF.
ACTION num Action Taken Collected at CRF.
PNO char Protocol Number Collected at CRF.
DRUGREL num Relationship To Study Drug Collected at CRF.
SEXAE char Sex Specific AE Collected at CRF.
BODYSYS char Body System Collected at CRF.
PREF_TRM char Perferred Term Collected at CRF.
PERIOD num Medication Period Collected at CRF.
ACTIONF char Action Taken Collected at CRF.
DRUGRELF char Relationship To Study Drug Collected at CRF.
SEVERITF char Severity Collected at CRF.
SERIOUSF char Serious AE Collected at CRF.
DURDAY num Duration of AE Collected at CRF.
STUDYDAY num Study Day Collected at CRF.
STATUSDY num Relative Completion Status Day If STATUSDT and REF.DATE not missing then
perform below logic to calculate STATUSDY, If
STATUSDT less than REF.DATE then (STATUSDT -
REF.DATE). Else if STATUSDT is greater than equal to REF.DATE then (STATUSDT- REF.DATE) +1.
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1.4.32. Keycurm - KEYCURM
Dataset KEYCURM
Creating program keycurm.sas
Description Keycurm
Unique identifier DPATNO,VISITNO,CSTARTDY,CSTOPDY,DRUGCODE,TOTDOSE
Sorted by DPATNO,VISITNO,CSTARTDY,CSTOPDY,DRUGCODE,TOTDOSE
Notes Below listed variables will be dropped from dataset to protect PII as per HIPAA and EMA guidelines or due to repetition of the information or due to non significant elements: VERBATIM,CSTART,CSTOP,INDICAT,ORIG_TXT,_USER_,_DATE_,INDICT, CSTARTDT,CSTOPDT,GENDESC,ATC_CD,ATC_TEXT,INO,DATE,INVNAME,SURN,FORE,MEDSTRDT
Variable Type Label Codes Comments
PNO char Protocol Number Collected at CRF.
DPATNO num Patient Number Assigned for De-Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
DEATHDY num Relative Day of Death If DEATHDT and REF.DATE not missing then
perform below logic to calculate DEATHDY, If
DEATHDT less than REF.DATE then (DEATHDT -
REF.DATE). Else if DEATHDT is greater than equal to REF.DATE then (DEATHDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 68 | 155
Variable Type Label Codes Comments
WEEK num Study Week Collected at CRF.
CONMED num Con Med Given? Collected at CRF.
DRUGCODE char Who Art Code Collected at CRF.
BY_WHODR char By_Whodr Collected at CRF.
CSTARTF num Cstartf Collected at CRF.
CONT num Con Med Continued Collected at CRF.
CSTOPF num Cstopf Collected at CRF.
ROUTE char Rt of Adm Collected at CRF.
TOTDOSE char Total Daily Dose Collected at CRF.
PRN num Prn Collected at CRF.
FORTAE num For Trt Emerg AE Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
DRUGDESC char Who Art Description Collected at CRF.
THERCLAS char Therapeutic*Class Collected at CRF.
PHRMCLAS char Pharmacologic*Class Collected at CRF.
PERIOD num Medication Period Collected at CRF.
CONTF char Con Med Continued Collected at CRF.
CONMEDF char Con Med Given? Collected at CRF.
FORTAEF char For Trt Emerg AE Collected at CRF.
STUDYDAY num Days On Study Collected at CRF.
DURATION num Duration of Conmed Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
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Variable Type Label Codes Comments
REGDAY num Days On Regimen Collected at CRF.
PHASE num Study Phase Collected at CRF.
CSTARTDY num Relative Con Med Start Day If CSTART and REF.DATE not missing then perform
below logic to calculate CSTARTDY, If CSTART less
than REF.DATE then (CSTART - REF.DATE). Else if
CSTART is greater than equal to REF.DATE then (CSTART- REF.DATE) +1.
CSTOPDY num Relative Con Med Stop Day If CSTOP and REF.DATE not missing then perform
below logic to calculate CSTOPDY, If CSTOP less
than REF.DATE then (CSTOP - REF.DATE). Else if
CSTOP is greater than equal to REF.DATE then (CSTOP- REF.DATE) +1.
KYCRM_TM num Time Collected at CRF.
KYCRM_DY num Relative Day If _DATE_ and REF.DATE not missing then perform
below logic to calculate KYCRM_DY, If _DATE_ less
than REF.DATE then (_DATE_ - REF.DATE). Else if
_DATE_ is greater than equal to REF.DATE then (_DATE_- REF.DATE) +1.
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Variable Type Label Codes Comments
DY num Relative Medication Start Day If DATE and REF.DATE not missing then perform
below logic to calculate DY, If DATE less than
REF.DATE then (DATE - REF.DATE). Else if DATE is
greater than equal to REF.DATE then (DATE- REF.DATE) +1.
MEDSTRDY num Relative First Med Day If MEDSTRDT and REF.DATE not missing then
perform below logic to calculate MEDSTRDY, If
MEDSTRDT less than REF.DATE then (MEDSTRDT -
REF.DATE). Else if MEDSTRDT is greater than equal to REF.DATE then (MEDSTRDT- REF.DATE) +1.
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1.4.33. Keydose - KEYDOSE
Dataset KEYDOSE
Creating program keydose.sas
Description Keydose
Unique identifier DPATNO
Sorted by DPATNO
Notes Below listed variables will be dropped from dataset due to non significant
elements or due to repetition of the information or due to missing values: EPO,DATE,STARTDT,STOPDT,MEDSTRTM,MEDSTPTM,RTITLE1,RTITLE2,
RTITLE3,REGIMEN
Variable Type Label Codes Comments
PNO char Protocol Number Collected at CRF.
DPATNO num Patient Number Assigned for De-Identity
Randomly assigned Patient Number for de-identity
PERIOD num Period For Initiation of Study Med Collected at CRF.
SEQUENCE num Treatment Sequence Collected at CRF.
XORDER num Cross-Over Order Collected at CRF.
THRPYDAY num Total Days On Therapy Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 72 | 155
Variable Type Label Codes Comments
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
STOPDY num Relative Medication Stop Day If STOPDT and REF.DATE not missing then perform
below logic to calculate STOPDY, If STOPDT less
than REF.DATE then (STOPDT - REF.DATE). Else if
STOPDT is greater than equal to REF.DATE then (STOPDT- REF.DATE) +1.
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1.4.34. Keylab1 - KEYLAB1
Dataset KEYLAB1
Creating program keylab1.sas
Description Keylab1
Unique identifier DPATNO,VISITNO,WEEK,LABDY,STOPDY,LABCODE
Sorted by DPATNO,VISITNO,WEEK,LABDY,STOPDY,LABCODE
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
missing values:
LABDATE,LABDT,SAMPDT,COLLECT,COLLECTF,FLAGF,LABLOC,ENDPT,DATE,
STARTDT,REC_ID,COLORD,COLORDF,ORIGFLAG,BIRTHDT,SEX,AGE,SASDATE,
STOPDT,START,STOP
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
LABDATEF num Code For Missing Dates Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
PNO char Protocol Number Collected at CRF.
LABCODE char Lab Code Collected at CRF.
RESULT num Lab Value Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
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Variable Type Label Codes Comments
CRESULT char Character Result Value Collected at CRF.
PAG_NAME char Page Name of Crf Collected at CRF.
PHASE num Phase Collected at CRF.
VISITYPE num Visit Type Collected at CRF.
VISITYPF char Formatted Visit Type Collected at CRF.
UNITCODE num Code For Collected Lab Unit Collected at CRF.
UNIT char Unit For Lab Collected at CRF.
LABCLASS char H, C, Or U Collected at CRF.
SIVAL num Si Value Collected at CRF.
SIUNIT char Si Unit Format Collected at CRF.
SICODE num Code For Si Unit Collected at CRF.
BASELINE num Baseline Value Collected at CRF.
CHGBASE num Change From Baseline Collected at CRF.
PCTCHG num % Change From Baseline Collected at CRF.
BASEFLAG char Baseline Flag Collected at CRF.
LABORDER num Sort Order Collected at CRF.
SIFMT char Sifmt Collected at CRF.
LABDESC char Full Lab Description Collected at CRF.
LABTST char Abbreviated Lab Description Collected at CRF.
STUDYDAY num Day of Treatment Collected at CRF.
CENTRAL char Central Collected at CRF.
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Variable Type Label Codes Comments
NEWVIS num Newvis Collected at CRF.
LOAGE num Loage Collected at CRF.
HIAGE num Hiage Collected at CRF.
LORANGE num Lorange Collected at CRF.
HIRANGE num Hirange Collected at CRF.
I num I Collected at CRF.
FLAG char Flag Collected at CRF.
LABDY num Relative Lab Day If LABDT and REF.DATE not missing then perform
below logic to calculate LABDY, If LABDT less than
REF.DATE then (LABDT - REF.DATE). Else if LABDT is
greater than equal to REF.DATE then (LABDT- REF.DATE) +1.
SAMPDY num Relative Sample Day If SAMPDT and REF.DATE not missing then perform
below logic to calculate SAMPDY, If SAMPDT less
than REF.DATE then (SAMPDT - REF.DATE). Else if
SAMPDT is greater than equal to REF.DATE then
(SAMPDT- REF.DATE) +1.
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
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Variable Type Label Codes Comments
SASDY num SAS Day If SASDATE and REF.DATE not missing then
perform below logic to calculate SASDY, If
SASDATE less than REF.DATE then (SASDATE -
REF.DATE). Else if SASDATE is greater than equal to REF.DATE then (SASDATE- REF.DATE) +1.
STOPDY num Relative Stop Day of AE If STOPDT and REF.DATE not missing then perform
below logic to calculate STOPDY, If STOPDT less
than REF.DATE then (STOPDT - REF.DATE). Else if
STOPDT is greater than equal to REF.DATE then (STOPDT- REF.DATE) +1.
STARTDY num Relative Start Day If START and REF.DATE not missing then perform
below logic to calculate STARTDY, If START less
than REF.DATE then (START - REF.DATE). Else if
START is greater than equal to REF.DATE then (START- REF.DATE) +1.
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1.4.35. Keysae - KEYSAE
Dataset KEYSAE
Creating program keysae.sas
Description Keysae
Unique identifier DPATNO,ONSETDY,STOPDY,BODYSYS,EVENT_ID
Sorted by DPATNO,ONSETDY,STOPDY,BODYSYS,EVENT_ID
Notes Below listed variables will be dropped from dataset due to non significant
elements or due to repetition of the information or due to missing values: VERBATIM,STOPDT,ONSETDT,ADVDESC,REGDAY,STOPTIME,TONSET
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-Identity
Randomly assigned Patient Number for de-identity
ADVEXP num AE Occured Collected at CRF.
ADVCODE char Whoart Code Collected at CRF.
SEVERITY num Severity Collected at CRF.
SERIOUS num Serious AE Collected at CRF.
ACTION num Action Taken Collected at CRF.
CONCOM num Con Med Given Collected at CRF.
OUTCOME num AE Outcome Collected at CRF.
EVENT_ID char Visit Number Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 78 | 155
Variable Type Label Codes Comments
PNO char Protocol Number Collected at CRF.
DRUGREL num Drug Delationship Collected at CRF.
SEXAE char Sex Specific AE Collected at CRF.
BODYSYS char Body System Collected at CRF.
PREF_TRM char Perferred Term Collected at CRF.
TRTMENTF char Treatment Collected at CRF.
TRTMENT num Treatment Code Collected at CRF.
PERIOD num Treatment Period Collected at CRF.
OUTCOMEF char AE Outcome Collected at CRF.
CONCOMF char Con Med Given Collected at CRF.
ACTIONF char Action Taken Collected at CRF.
DRUGRELF char Drug Delationship Collected at CRF.
SEVERITF char Severity Collected at CRF.
SERIOUSF char Serious AE Collected at CRF.
ADVEXPF char Ae Occured Collected at CRF.
DURDAY num Duration of AE Collected at CRF.
STUDYDAY num Study Day Collected at CRF.
PHASE num Study Phase Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 79 | 155
Variable Type Label Codes Comments
STOPDY num Relative AE Stop Day If STOPDT and REF.DATE not missing then perform
below logic to calculate STOPDY, If STOPDT less
than REF.DATE then (STOPDT - REF.DATE). Else if
STOPDT is greater than equal to REF.DATE then (STOPDT- REF.DATE) +1.
ONSETDY num Relative AE Onset Day If ONSETDT and REF.DATE not missing then
perform below logic to calculate ONSETDY, If
ONSETDT less than REF.DATE then (ONSETDT -
REF.DATE). Else if ONSETDT is greater than equal to REF.DATE then (ONSETDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 80 | 155
1.4.36. Keysae1 - KEYSAE1
Dataset KEYSAE1
Creating program keysae1.sas
Description Keysae1
Unique identifier DPATNO,ONSETDY,STOPDY,BODYSYS,EVENT_ID
Sorted by DPATNO,ONSETDY,STOPDY,BODYSYS,EVENT_ID
Notes Below listed variables will be dropped from dataset due to non significant
elements or due to repetition of the information or due to missing values: VERBATIM,STOPDT,ONSETDT,ADVDESC,REGDAY,STOPTIME,TONSET
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-Identity
Randomly assigned Patient Number for de-identity
ADVEXP num AE Occured Collected at CRF.
ADVCODE char Who Art Code Collected at CRF.
SEVERITY num Severity Collected at CRF.
SERIOUS num Serious AE Collected at CRF.
ACTION num Action Taken Collected at CRF.
CONCOM num Com Med Given Collected at CRF.
OUTCOME num Outcome of AE Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 81 | 155
Variable Type Label Codes Comments
PNO char Protocol Number Collected at CRF.
DRUGREL num Relationship To Study Drug Collected at CRF.
SEXAE char Sex Specific AE Collected at CRF.
BODYSYS char Body System Collected at CRF.
PREF_TRM char Perferred Term Collected at CRF.
TRTMENTF char Treatment Collected at CRF.
TRTMENT num Treatment Code Collected at CRF.
PERIOD num Medication Period Collected at CRF.
OUTCOMEF char Outcome of AE Collected at CRF.
CONCOMF char Com Med Given Collected at CRF.
ACTIONF char Action Taken Collected at CRF.
DRUGRELF char Relationship To Study Drug Collected at CRF.
SEVERITF char Severity Collected at CRF.
SERIOUSF char Serious AE Collected at CRF.
ADVEXPF char AE Occured Collected at CRF.
DURDAY num Duration of AE Collected at CRF.
STUDYDAY num Study Day Collected at CRF.
PHASE num Study Phase Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 82 | 155
Variable Type Label Codes Comments
STOPDY num Relative Stop Day of AE If STOPDT and REF.DATE not missing then perform
below logic to calculate STOPDY, If STOPDT less
than REF.DATE then (STOPDT - REF.DATE). Else if
STOPDT is greater than equal to REF.DATE then (STOPDT- REF.DATE) +1.
ONSETDY num Relative Onset Day of AE If ONSETDT and REF.DATE not missing then
perform below logic to calculate ONSETDY, If
ONSETDT less than REF.DATE then (ONSETDT -
REF.DATE). Else if ONSETDT is greater than equal to REF.DATE then (ONSETDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 83 | 155
1.4.37. Keysae2 - KAYSAE2
Dataset KEYSAE2
Creating program keysae2.sas
Description Keysae2
Unique identifier DPATNO,ONSETDY,STOPDY,ADVDESC,EVENT_ID
Sorted by DPATNO,ONSETDY,STOPDY,ADVDESC,EVENT_ID
Notes Below listed variables will be dropped from dataset due to non significant elements or due to repetition of the information or due to missing values: VERBATIM,STOPDT,ONSETDT,ADVDESC,REGDAY,STOPTIME,TONSET
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
ADVEXP num AE Occured Collected at CRF.
ADVCODE char Who Art Code Collected at CRF.
SEVERITY num Severity Collected at CRF.
SERIOUS num Serious AE Collected at CRF.
ACTION num Action Taken Collected at CRF.
CONCOM num Com Med Given Collected at CRF.
OUTCOME num Outcome of AE Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
PNO char Protocol Number Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 84 | 155
Variable Type Label Codes Comments
DRUGREL num Relationship To Study Drug Collected at CRF.
SEXAE char Sex Specific AE Collected at CRF.
BODYSYS char Body System Collected at CRF.
PREF_TRM char Perferred Term Collected at CRF.
TRTMENTF char Treatment Collected at CRF.
TRTMENT num Treatment Code Collected at CRF.
PERIOD num Medication Period Collected at CRF.
OUTCOMEF char Outcome of AE Collected at CRF.
CONCOMF char Com Med Given Collected at CRF.
ACTIONF char Action Taken Collected at CRF.
DRUGRELF char Relationship To Study Drug Collected at CRF.
SEVERITF char Severity Collected at CRF.
SERIOUSF char Serious AE Collected at CRF.
ADVEXPF char AE Occured Collected at CRF.
DURDAY num Duration of AE Collected at CRF.
STUDYDAY num Study Day Collected at CRF.
PHASE num Study Phase Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 85 | 155
Variable Type Label Codes Comments
STOPDY num Relative Stop Day of AE If STOPDT and REF.DATE not missing then perform
below logic to calculate STOPDY, If STOPDT less
than REF.DATE then (STOPDT - REF.DATE). Else if
STOPDT is greater than equal to REF.DATE then (STOPDT- REF.DATE) +1.
ONSETDY num Relative Onset Day of AE If ONSETDT and REF.DATE not missing then
perform below logic to calculate ONSETDY, If
ONSETDT less than REF.DATE then (ONSETDT -
REF.DATE). Else if ONSETDT is greater than equal to REF.DATE then (ONSETDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 86 | 155
1.4.38. Keyvit1 - KEYVIT1
Dataset KEYVIT1
Creating program keyvit1.sas
Description Keyvit1
Unique identifier DPATNO,VISITNO,EVDY,VORDER
Sorted by DPATNO,VISITNO,EVDY,VORDER
Notes Below listed variables will be dropped from dataset due to repetition of the information: VDATE,EVDATE,DATE,FRSTMED
Variable Type Label Codes Comments
PNO char Protocol Number Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Week of Visit Collected at CRF.
VDATEF num Visit Date Flag Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
VISITYPE num Visit Type Collected at CRF.
PHASE num Phase Collected at CRF.
PERIOD num Period Collected at CRF.
VITAL char Vital Sign Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 87 | 155
Variable Type Label Codes Comments
VALUE num Value Collected at CRF.
UNIT char Unit Collected at CRF.
VORDER num Order For Output Collected at CRF.
BASEFLAG char Baseline Flag Collected at CRF.
ENDPT char End Point Collected at CRF.
COLORDF char Format For Sort Collected at CRF.
CHGBASE num Change From Baseline Collected at CRF.
PCTCHG num Percent Change Collected at CRF.
COLORD num Sort Order Collected at CRF.
STUDYDAY num Study Day Collected at CRF.
REGDAY num Day Within Treatment Collected at CRF.
EVDY num Relative Visit Day If EVDATE and REF.DATE not missing then perform
below logic to calculate EVDY, If EVDATE less than
REF.DATE then (EVDATE - REF.DATE). Else if
EVDATE is greater than equal to REF.DATE then (EVDATE- REF.DATE) +1.
FRSTMEDY num Relative Medication Start Day If FRSTMED and REF.DATE not missing then
perform below logic to calculate FRSTMEDY, If
FRSTMED less than REF.DATE then (FRSTMED -
REF.DATE). Else if FRSTMED is greater than equal
to REF.DATE then (FRSTMED- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 88 | 155
1.4.39. Keyfile_2 - KFILE_2
Dataset KFILE_2
Creating program kfile_2.sas
Description Keyfile_2
Unique identifier DPATNO
Sorted by DPATNO
Notes Below listed variables will be dropped from dataset due to repetition of the information or due to missing values: SEX,SEXF,FER2,FE2,CFER2,CFE2,EFFF,EFF,METAF,META
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
TRTMENT num Trtment Collected at CRF.
TRTMENTF char Trtmentf Collected at CRF.
REGORDER num Regorder Collected at CRF.
TIMEDIAG num Time To Diagnosis In Months Collected at CRF.
PRETRND num At Prestudy Was Pat Trans
Dependent?
Collected at CRF.
PRETRNDF char Decode For Pretrnd (1=No, 2=Yes) Collected at CRF.
MDIAGNOS num Diagnosis of Malignancy Collected at CRF.
MDIAGNOF char Decode For Mdiagnos Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 89 | 155
Variable Type Label Codes Comments
EPO2 num Epo Level At Week=2 Collected at CRF.
WEEK num Study Week Collected at CRF.
BEPO num Baseline Epo Collected at CRF.
BWBC num Baseline Wbc Collected at CRF.
BHGB num Baseline Hgb Collected at CRF.
BHCT num Baseline Hct Collected at CRF.
BRCT num Baseline Rct Collected at CRF.
BFER num Baseline Ferritin Collected at CRF.
BFE num Baseline Transferrin Sat. Collected at CRF.
WBC2 num Wbc At Week 2 Collected at CRF.
HGB2 num Hgb At Week 2 Collected at CRF.
HCT2 num Hct At Week 2 Collected at CRF.
RCT2 num Rct At Week 2 Collected at CRF.
WBC4 num Wbc At Week 4 Collected at CRF.
HGB4 num Hgb At Week 4 Collected at CRF.
HCT4 num Hct At Week 4 Collected at CRF.
RCT4 num Rct At Week 4 Collected at CRF.
FER4 num Fer At Week 4 Collected at CRF.
FE4 num Transferrin Sat. At Week 4 Collected at CRF.
CWBC2 num Change From Base To Week 2 Collected at CRF.
CHGB2 num Change From Base To Week 2 Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 90 | 155
Variable Type Label Codes Comments
CHCT2 num Change From Base To Week 2 Collected at CRF.
CRCT2 num Change From Base To Week 2 Collected at CRF.
CWBC4 num Change From Base To Week 4 Collected at CRF.
CHGB4 num Change From Base To Week 4 Collected at CRF.
CHCT4 num Change From Base To Week 4 Collected at CRF.
CRCT4 num Change From Base To Week 4 Collected at CRF.
CFER4 num Change From Base To Week 4 Collected at CRF.
CFE4 num Change From Base To Week 4 Collected at CRF.
PNO char Protocol Number Collected at CRF.
BEPOCAT num Baseline Epo Category Collected at CRF.
BEPOCATF char Decoding For Bepocat Collected at CRF.
STUDY char Study Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 91 | 155
1.4.40. Labnorm - LABNORM
Dataset LABNORM
Creating program labnorm.sas
Description Labnorm
Unique identifier LABCODE,SEX
Sorted by LABCODE,SEX
Notes Below listed variables will be dropped from dataset due to repetition of the information or due to missing values: STOPDT
Variable Type Label Codes Comments
LABCODE char Labcode Collected at CRF.
LOAGE num Loage Collected at CRF.
HIAGE num Hiage Collected at CRF.
LORANGE num Lorange Collected at CRF.
HIRANGE num Hirange Collected at CRF.
UNIT char Unit Collected at CRF.
STARTDT char Start Date Collected at CRF.
LABLOC num Labloc Collected at CRF.
AGEUNIT char Ageunit Collected at CRF.
SEX char Sex Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 92 | 155
1.4.41. Labs - LABS
Dataset LABS
Creating program labs.sas
Description Labs
Unique identifier DPATNO,LABCODE,LABDY,EVENT_ID
Sorted by DPATNO,LABCODE,LABDY,EVENT_ID
Notes Below listed variables will be dropped from dataset to protect PII as per HIPAA and EMA guidelines or due to repetition of the information or due to non significant elements or due to missing values: LABDATE,LABSPEC,COL2,LABDT,SAMPDT,COLLECT,COLLECTF,SAMPTIME, FLAG,FLAGF,LABLOC,UNITCODE,REC_ID
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
LABDATEF num Labdatef Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
PNO char Protocol Number Collected at CRF.
LABCODE char Name of Former Variable Collected at CRF.
RESULT num Result Collected at CRF.
CRESULT char Cresult Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 93 | 155
Variable Type Label Codes Comments
PAG_NAME char Pag_Name Collected at CRF.
PHASE num Phase Collected at CRF.
VISITYPE num Visit Type Collected at CRF.
VISITYPF char Formatted Visit Type Collected at CRF.
LABDY num Relative Lab Day If LABDT and REF.DATE not missing then perform
below logic to calculate LABDY, If LABDT less than
REF.DATE then (LABDT - REF.DATE). Else if LABDT is
greater than equal to REF.DATE then (LABDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 94 | 155
1.4.42. Labs1 - LABS1
Dataset LABS1
Creating program labs1.sas
Description Labs1
Unique identifier DPATNO,LABCODE,LABDY,EVENT_ID
Sorted by DPATNO,LABCODE,LABDY,EVENT_ID
Notes Below listed variables will be dropped from dataset to protect PII as per HIPAA and EMA guidelines or due to repetition of the information or due to missing values: LABDATE,LABDT,SAMPDT,COLLECT,COLLECTF,FLAG,FLAGF,LABLOC,ENDPT, DATE,STARTDT,REC_ID,COLORD,COLORDF
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
LABDATEF num Code For Missing Dates Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
PNO char Protocol Number Collected at CRF.
LABCODE char Lab Code Collected at CRF.
RESULT num Lab Value Collected at CRF.
CRESULT char Character Result Value Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 95 | 155
Variable Type Label Codes Comments
PAG_NAME char Page Name of Crf Collected at CRF.
PHASE num Phase Collected at CRF.
VISITYPE num Visit Type Collected at CRF.
VISITYPF char Formatted Visit Type Collected at CRF.
UNITCODE num Code For Collected Lab Unit Collected at CRF.
UNIT char Unit For Lab Collected at CRF.
LABCLASS char H, C, Or U Collected at CRF.
SIVAL num Si Value Collected at CRF.
SIUNIT char Si Unit Format Collected at CRF.
SICODE num Code For Si Unit Collected at CRF.
BASELINE num Baseline Value Collected at CRF.
CHGBASE num Change From Baseline Collected at CRF.
PCTCHG num % Change From Baseline Collected at CRF.
BASEFLAG char Baseline Flag Collected at CRF.
LABORDER num Sort Order Collected at CRF.
SIFMT char Sifmt Collected at CRF.
LABDESC char Full Lab Description Collected at CRF.
LABTST char Abbreviated Lab Description Collected at CRF.
STUDYDAY num Day of Treatment Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 96 | 155
Variable Type Label Codes Comments
LABDY num Relative Lab Day If LABDT and REF.DATE not missing then perform
below logic to calculate LABDY, If LABDT less than
REF.DATE then (LABDT - REF.DATE). Else if LABDT is
greater than equal to REF.DATE then (LABDT- REF.DATE) +1.
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 97 | 155
1.4.43. Medical History - MEDHIS
Dataset MEDHIS
Creating program medhis.sas
Description Medical History
Unique identifier DPATNO
Sorted by DPATNO
Notes Below listed variables will be dropped from dataset to protect PII as per HIPAA and EMA guidelines or due to repetition of the information or due to missing values: INIT,INO,VDATE,VISITNO,EVENT_ID
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VDATEF num Vdatef Collected at CRF.
EYES num Eyes Collected at CRF.
RESP num Respiratory Collected at CRF.
CARD num Cardiovascular Collected at CRF.
GAST num Gastrointestinal Collected at CRF.
GENI num Genito-Urinary Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 98 | 155
Variable Type Label Codes Comments
MUSC num Musculoskeleton Collected at CRF.
NEUR num Neurologic Collected at CRF.
ENDO num Endocrine &Metabolic Collected at CRF.
HEMA num Hematopoietic/Lymphatic Collected at CRF.
DERM num Dermatologic Collected at CRF.
PSYCH num Psychological Collected at CRF.
VDY num Visit Day If VDATE and REF.DATE not missing then perform
below logic to calculate VDY, If VDATE less than
REF.DATE then (VDATE - REF.DATE). Else if VDATE
is greater than equal to REF.DATE then (VDATE- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 99 | 155
1.4.44. Normalsi - NORMALSI
Dataset NORMALSI
Creating program normalsi.sas
Description Normalsi
Unique identifier SEX,VARNAM,OBSNO,LR
Sorted by SEX,VARNAM,OBSNO,LR
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
missing values: INO,AGE_L,VISITNO,EVENT_ID
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
SEX num Sex Collected at CRF.
VARNAM char Varnam Collected at CRF.
AGE_U num Age_U Collected at CRF.
LR num Lr Collected at CRF.
UR num Ur Collected at CRF.
UNIT char Unit Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 100 | 155
1.4.45. Otherlab - OTHERLAB
Dataset OTHERLAB
Creating program otherlab.sas
Description Otherlab
Unique identifier DPATNO,VISITNO,LABDY,LABCODE
Sorted by DPATNO,VISITNO,LABDY,LABCODE
Notes Below listed variables will be dropped from dataset due to non significant elements or due to repetition of the information or due to missing values: LABDATE,LABSPEC,CRESULT,LABDT,SAMPDT,COLLECT,COLLECTF,SAMPTIME, FLAG,FLAGF,UNITCODE,REC_ID
Variable Type Label Codes Comments
PNO char Protocol Number Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
LABDATEF num Labdatef Collected at CRF.
RESULT num Result Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
LABCODE char Labcode Collected at CRF.
U319 char U319 Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 101 | 155
Variable Type Label Codes Comments
U303 num U303 Collected at CRF.
U304 num U304 Collected at CRF.
LABDESC char Labdesc Collected at CRF.
PAG_NAME char Pag_Name Collected at CRF.
PHASE num Phase Collected at CRF.
VISITYPE num Visit Type Collected at CRF.
VISITYPF char Formatted Visit Type Collected at CRF.
LABLOC num Labloc Collected at CRF.
LABDY num Relative Lab Day If LABDT and REF.DATE not missing then perform
below logic to calculate LABDY, If LABDT less than
REF.DATE then (LABDT - REF.DATE). Else if LABDT is
greater than equal to REF.DATE then (LABDT- REF.DATE) +1.
SAMPDY num Relative Sample Day If SAMPDT and REF.DATE not missing then perform
below logic to calculate SAMPDY, If SAMPDT less
than REF.DATE then (SAMPDT - REF.DATE). Else if
SAMPDT is greater than equal to REF.DATE then (SAMPDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 102 | 155
1.4.46. Performance Score - PERFOR
Dataset PERFOR
Creating program perfor.sas
Description Performance Score
Unique identifier DPATNO,VISITNO
Sorted by DPATNO,VISITNO
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information:
INIT,INO,VDATE
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
VDATEF num Vdatef Collected at CRF.
PERFOR num Perfor Collected at CRF.
PHYSI char Physi Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 103 | 155
Variable Type Label Codes Comments
EVENT_ID char Event_Id Collected at CRF.
VDY num Visit Day If VDATE and REF.DATE not missing then perform
below logic to calculate VDY, If VDATE less than
REF.DATE then (VDATE - REF.DATE). Else if VDATE
is greater than equal to REF.DATE then (VDATE- REF.DATE) +1.
1.4.47. Initial Physical Examination - PHYSEX
Dataset PHYSEX
Creating program physex.sas
Description Initial Physical Examination
Unique identifier DPATNO,VISITNO
Sorted by DPATNO,VISITNO
Notes Below listed variables will be dropped from dataset to protect PII as per HIPAA and EMA guidelines or due to repetition of the information: INIT,INO,VDATE,OTHERC
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 104 | 155
Variable Type Label Codes Comments
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
VDATEF num Vdatef Collected at CRF.
HEAD num Head Collected at CRF.
EARS num Ears Collected at CRF.
EYES num Eyes Collected at CRF.
CHEST num Chest Collected at CRF.
LUNGS num Lungs Collected at CRF.
HEART num Heart Collected at CRF.
LYMPH num Lymph Collected at CRF.
ABDOMEN num Abdomen Collected at CRF.
ANORE num Anore Collected at CRF.
GENIT num Genit Collected at CRF.
SKIN num Skin Collected at CRF.
MUSC num Musc Collected at CRF.
NEURO num Neuro Collected at CRF.
OTHER num Other Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 105 | 155
Variable Type Label Codes Comments
EVENT_ID char Event_Id Collected at CRF.
VDY num Visit Day If VDATE and REF.DATE not missing then perform
below logic to calculate VDY, If VDATE less than
REF.DATE then (VDATE - REF.DATE). Else if VDATE
is greater than equal to REF.DATE then (VDATE- REF.DATE) +1.
1.4.48. Initial Blood Pressure, Ht., Wt. - PPVI
Dataset PPVI
Creating program ppvi.sas
Description Initial Blood Pressure, Ht., Wt.
Unique identifier DPATNO,VISITNO,WEEK,VDY,OBSNO
Sorted by DPATNO,VISITNO,WEEK,VDY,OBSNO
Notes Below listed variables will be dropped from dataset to protect PII as per HIPAA and EMA guidelines or due to repetition of the information: INIT,INO,VDATE
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 106 | 155
Variable Type Label Codes Comments
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
VDATEF num Vdatef Collected at CRF.
SBP num Sbp Collected at CRF.
DBP num Dbp Collected at CRF.
HEIGHT num Height Collected at CRF.
WEIGHT num Weight Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
VDY num Visit Day If VDATE and REF.DATE not missing then perform
below logic to calculate VDY, If VDATE less than
REF.DATE then (VDATE - REF.DATE). Else if VDATE
is greater than equal to REF.DATE then (VDATE- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 107 | 155
1.4.49. Profdose - PROFDOSE
Dataset PROFDOSE
Creating program profdose.sas
Description Profdose
Unique identifier DPATNO
Sorted by DPATNO
Notes Below listed variables will be dropped from dataset to protect PII as per HIPAA and EMA guidelines or due to repetition of the information or due to non significant elements or due to missing values: EPO,DATE,STARTDT,STOPDT,MEDSTRTM,MEDSTPTM,RTITLE2,RTITLE3, REGIMEN,INO,COUNTRY,VDATE,BIRTHDT,SEX,RACE,RACESPEC,DTERM, STATUSDT,DEATHDT,LEPODT,DBENDDT,DIAGDT,LCHEMDT,SEXF,COUNTRYF, CNTRY,RACEF,AGE,INVNAME,SURN,FORE,OTHRSPEC,AGEUNIT
Variable Type Label Codes Comments
PNO char Protocol Number Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
PERIOD num Period For Initiation of Study Med Collected at CRF.
SEQUENCE num Treatment Sequence Collected at CRF.
XORDER num Cross-Over Order Collected at CRF.
RTITLE1 char First Regimen Title Collected at CRF.
THRPYDAY num Total Days On Therapy Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 108 | 155
Variable Type Label Codes Comments
CRESP num Patient's Response To
Chemotherapy
Collected at CRF.
STATUS num Completion Status Collected at CRF.
DEATH num Death Collected at CRF.
REASON num Discontinuation Reason Collected at CRF.
BASEHGT num Baseline Height Collected at CRF.
BASEWGT num Baseline Weight Collected at CRF.
OL num Was Patient In Open-Label Study Collected at CRF.
CHEMOTYP num Type of Chemotherapy Collected at CRF.
CHEMOTYF char Decode For Chemotyp Collected at CRF.
DIAGF num Flag For Diagdt Collected at CRF.
MDIAGNOS num Diagnosis of Malignancy Collected at CRF.
PERFPRE num Performance Score At Prestudy Collected at CRF.
PERFTERM num Performance Score At Termination Collected at CRF.
PHYSDB char Physician'S Global Assess. At Wk 12 Collected at CRF.
PHYSOL char Physician'S Global Assess. At Wk 24 Collected at CRF.
PERFCHG num Chge In Perform From Pre To Term Collected at CRF.
CHEMOYN num Did Pat Receive Chemo Dur Past 6
Mon
Collected at CRF.
PRECHEMO num Did Pat Have Chemo In Past 3 Mon Collected at CRF.
CYCLES num # of Chemo Cycles In Past 6 Mon Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 109 | 155
Variable Type Label Codes Comments
REGORDER num Order of Regimens Collected at CRF.
REGDESC char Treatment Collected at CRF.
TRTMENTF char Treatment Collected at CRF.
REASONF char Discontinuation Reason Collected at CRF.
PHYSDBF char Decode For Physdb Collected at CRF.
PHYSOLF char Decode For Physol Collected at CRF.
STATUSF char Completion Status Collected at CRF.
CRESPF char Decode For Cresp Collected at CRF.
MDIAGNOF char Decode For Mdiagnos Collected at CRF.
OLF char Decode For Ol Collected at CRF.
CHEMOYNF char Decode For Chemoyn (1=No,
2=Yes)
Collected at CRF.
PRECHEMF char Decode For Prechemo (1=No,
2=Yes)
Collected at CRF.
DIAGDTF char Flag For Missing Parts of Dates Collected at CRF.
COMPDAYS num Number of Days To Study
Completion
Collected at CRF.
TIMEDIAG num Time To Diagnosis In Months Collected at CRF.
TRTMENT num Treatment Code Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 110 | 155
Variable Type Label Codes Comments
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
STOPDY num Relative Medication Stop Day If STOPDT and REF.DATE not missing then perform
below logic to calculate STOPDY, If STOPDT less
than REF.DATE then (STOPDT - REF.DATE). Else if
STOPDT is greater than equal to REF.DATE then (STOPDT- REF.DATE) +1.
VDY num Relative Visit Day In Demo Dataset If VDATE and REF.DATE not missing then perform
below logic to calculate VDY, If VDATE less than
REF.DATE then (VDATE - REF.DATE). Else if VDATE
is greater than equal to REF.DATE then (VDATE- REF.DATE) +1.
STATUSDY num Relative Completion Status Day If STATUSDT and REF.DATE not missing then
perform below logic to calculate STATUSDY, If
STATUSDT less than REF.DATE then (STATUSDT -
REF.DATE). Else if STATUSDT is greater than equal to REF.DATE then (STATUSDT- REF.DATE) +1.
DEATHDY num Relative Day of Death If DEATHDT and REF.DATE not missing then
perform below logic to calculate DEATHDY, If
DEATHDT less than REF.DATE then (DEATHDT -
REF.DATE). Else if DEATHDT is greater than equal to REF.DATE then (DEATHDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 111 | 155
Variable Type Label Codes Comments
LEPODY num Relative Day of Last Study Dose If LEPODT and REF.DATE not missing then perform
below logic to calculate LEPODY, If LEPODT less
than REF.DATE then (LEPODT - REF.DATE). Else if
LEPODT is greater than equal to REF.DATE then (LEPODT- REF.DATE) +1.
DBENDDY num Relative Last Day of Double-Blind
Phase
If DBENDDT and REF.DATE not missing then
perform below logic to calculate DBENDDY, If
DBENDDT less than REF.DATE then (DBENDDT -
REF.DATE). Else if DBENDDT is greater than equal to REF.DATE then (DBENDDT- REF.DATE) +1.
DIAGDY num Relative Day of Diagnosis of
Malignancy
If DIAGDT and REF.DATE not missing then perform
below logic to calculate DIAGDY, If DIAGDT less
than REF.DATE then (DIAGDT - REF.DATE). Else if
DIAGDT is greater than equal to REF.DATE then (DIAGDT- REF.DATE) +1.
LCHEMDY num Relative Day of Last Chemotherapy If LCHEMDT and REF.DATE not missing then
perform below logic to calculate LCHEMDY, If
LCHEMDT less than REF.DATE then (LCHEMDT -
REF.DATE). Else if LCHEMDT is greater than equal to REF.DATE then (LCHEMDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 112 | 155
1.4.50. Profeval - PROFEVAL
Dataset PROFEVAL
Creating program profeval.sas
Description Profeval
Unique identifier DPATNO
Sorted by DPATNO
Notes Below listed variables will be dropped from dataset to protect PII as per HIPAA and EMA guidelines or due to repetition of the information or due to missing values: INO,INVNAME,COUNTRY,VDATE,BIRTHDT,SEX,RACE,RACESPEC,EPO,DTERM, STATUSDT,DEATHDT,LEPODT,DATE,STARTDT,DBENDDT,DIAGDT,LCHEMDT, SEXF,COUNTRYF,CNTRY,RACEF,AGE,SURN,FORE,OTHRSPEC,AGEUNIT
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
REGORDER num Order of Regimens Collected at CRF.
REGDESC char Treatment Collected at CRF.
EFFC num Is Patient Evaluable For Efficacy
Analys
Collected at CRF.
ITT num Is Patient Evaluable Fot Itt Analysis Collected at CRF.
TUMORTYP num Tumor Type Collected at CRF.
TUMORTYF char Decode For Ttype Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
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Variable Type Label Codes Comments
SAF num Is Patient Evaluable For Safety
Analysis
Collected at CRF.
EFF num Is Patient Evaluable For Efficacy
Analys
Collected at CRF.
EFFF char Decode For Eff (1=No, 2=Yes) Collected at CRF.
EFFCF char Decode For Eff (1=No, 2=Yes) Collected at CRF.
ITTF char Decode For Itt (1=No, 2=Yes) Collected at CRF.
SAFF char Decode For Saf (1=No, 2=Yes) Collected at CRF.
PNO char Protocol Number Collected at CRF.
CRESP num Patient's Response To
Chemotherapy
Collected at CRF.
STATUS num Completion Status Collected at CRF.
DEATH num Death Collected at CRF.
REASON num Discontinuation Reason Collected at CRF.
BASEHGT num Baseline Height Collected at CRF.
BASEWGT num Baseline Weight Collected at CRF.
OL num Was Patient In Open-Label Study Collected at CRF.
CHEMOTYP num Type of Chemotherapy Collected at CRF.
CHEMOTYF char Decode For Chemotyp Collected at CRF.
DIAGF num Flag For Diagdt Collected at CRF.
MDIAGNOS num Diagnosis of Malignancy Collected at CRF.
PERFPRE num Performance Score At Prestudy Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 114 | 155
Variable Type Label Codes Comments
PERFTERM num Performance Score At Termination Collected at CRF.
PHYSDB char Physician'S Global Assess. At Wk 12 Collected at CRF.
PHYSOL char Physician'S Global Assess. At Wk 24 Collected at CRF.
PERFCHG num Chge In Perform From Pre To Term Collected at CRF.
CHEMOYN num Did Pat Receive Chemo Dur Past 6
Mon
Collected at CRF.
PRECHEMO num Did Pat Have Chemo In Past 3 Mon Collected at CRF.
CYCLES num # of Chemo Cycles In Past 6 Mon Collected at CRF.
TRTMENTF char Treatment Collected at CRF.
REASONF char Discontinuation Reason Collected at CRF.
PHYSDBF char Decode For Physdb Collected at CRF.
PHYSOLF char Decode For Physol Collected at CRF.
STATUSF char Completion Status Collected at CRF.
CRESPF char Decode For Cresp Collected at CRF.
MDIAGNOF char Decode For Mdiagnos Collected at CRF.
OLF char Decode For Ol Collected at CRF.
CHEMOYNF char Decode For Chemoyn (1=No,
2=Yes)
Collected at CRF.
PRECHEMF char Decode For Prechemo (1=No,
2=Yes)
Collected at CRF.
DIAGDTF char Flag For Missing Parts of Dates Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 115 | 155
Variable Type Label Codes Comments
COMPDAYS num Number of Days To Study
Completion
Collected at CRF.
TIMEDIAG num Time To Diagnosis In Months Collected at CRF.
TRTMENT num Treatment Code Collected at CRF.
VDY num Relative Visit Day In Demo Dataset If VDATE and REF.DATE not missing then perform
below logic to calculate VDY, If VDATE less than
REF.DATE then (VDATE - REF.DATE). Else if VDATE
is greater than equal to REF.DATE then (VDATE- REF.DATE) +1.
STATUSDY num Relative Completion Status Day If STATUSDT and REF.DATE not missing then
perform below logic to calculate STATUSDY, If
STATUSDT less than REF.DATE then (STATUSDT -
REF.DATE). Else if STATUSDT is greater than equal to REF.DATE then (STATUSDT- REF.DATE) +1.
DEATHDY num Relative Day of Death If DEATHDT and REF.DATE not missing then
perform below logic to calculate DEATHDY, If
DEATHDT less than REF.DATE then (DEATHDT -
REF.DATE). Else if DEATHDT is greater than equal to REF.DATE then (DEATHDT- REF.DATE) +1.
LEPODY num Relative Day of Last Study Dose If LEPODT and REF.DATE not missing then perform
below logic to calculate LEPODY, If LEPODT less
than REF.DATE then (LEPODT - REF.DATE). Else if
LEPODT is greater than equal to REF.DATE then (LEPODT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 116 | 155
Variable Type Label Codes Comments
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
DBENDDY num Relative Last Day of Double-Blind
Phase
If DBENDDT and REF.DATE not missing then
perform below logic to calculate DBENDDY, If
DBENDDT less than REF.DATE then (DBENDDT -
REF.DATE). Else if DBENDDT is greater than equal to REF.DATE then (DBENDDT- REF.DATE) +1.
DIAGDY num Relative Day of Diagnosis of
Malignancy
If DIAGDT and REF.DATE not missing then perform
below logic to calculate DIAGDY, If DIAGDT less
than REF.DATE then (DIAGDT - REF.DATE). Else if
DIAGDT is greater than equal to REF.DATE then (DIAGDT- REF.DATE) +1.
LCHEMDY num Relative Day of Last Chemotherapy If LCHEMDT and REF.DATE not missing then
perform below logic to calculate LCHEMDY, If
LCHEMDT less than REF.DATE then (LCHEMDT -
REF.DATE). Else if LCHEMDT is greater than equal to REF.DATE then (LCHEMDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 117 | 155
1.4.51. Profex - PROFEX
Dataset PROFEX
Creating program profex.sas
Description Profex
Unique identifier DPATNO
Sorted by DPATNO
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
missing values:
INO,COUNTRY,VDATE,BIRTHDT,SEX,RACE,RACESPEC,EPO,DTERM,STATUSDT,
DEATHDT,LEPODT,DATE,STARTDT,DBENDDT,DIAGDT,LCHEMDT,SEXF,COUNTRYF,CNTRY,RACEF,AGE,INVNAME,SURN,FORE,OTHRSPEC,AGEUNIT
Variable Type Label Codes Comments
PNO char Protocol Number Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
CRESP num Patient's Response To
Chemotherapy
Collected at CRF.
STATUS num Completion Status Collected at CRF.
DEATH num Death Collected at CRF.
REASON num Discontinuation Reason Collected at CRF.
BASEHGT num Baseline Height Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 118 | 155
Variable Type Label Codes Comments
BASEWGT num Baseline Weight Collected at CRF.
OL num Was Patient In Open-Label Study Collected at CRF.
CHEMOTYP num Type of Chemotherapy Collected at CRF.
CHEMOTYF char Decode For Chemotyp Collected at CRF.
DIAGF num Flag For Diagdt Collected at CRF.
MDIAGNOS num Diagnosis of Malignancy Collected at CRF.
PERFPRE num Performance Score At Prestudy Collected at CRF.
PERFTERM num Performance Score At Termination Collected at CRF.
PHYSDB char Physician'S Global Assess. At Wk 12 Collected at CRF.
PHYSOL char Physician'S Global Assess. At Wk 24 Collected at CRF.
PERFCHG num Chge In Perform From Pre To Term Collected at CRF.
CHEMOYN num Did Pat Receive Chemo Dur Past 6
Mon
Collected at CRF.
PRECHEMO num Did Pat Have Chemo In Past 3 Mon Collected at CRF.
CYCLES num # of Chemo Cycles In Past 6 Mon Collected at CRF.
REGORDER num Order of Regimens Collected at CRF.
REGDESC char Treatment Collected at CRF.
TRTMENTF char Treatment Collected at CRF.
REASONF char Discontinuation Reason Collected at CRF.
PHYSDBF char Decode For Physdb Collected at CRF.
PHYSOLF char Decode For Physol Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 119 | 155
Variable Type Label Codes Comments
STATUSF char Completion Status Collected at CRF.
CRESPF char Decode For Cresp Collected at CRF.
MDIAGNOF char Decode For Mdiagnos Collected at CRF.
OLF char Decode For Ol Collected at CRF.
CHEMOYNF char Decode For Chemoyn (1=No,
2=Yes)
Collected at CRF.
PRECHEMF char Decode For Prechemo (1=No,
2=Yes)
Collected at CRF.
DIAGDTF char Flag For Missing Parts of Dates Collected at CRF.
COMPDAYS num Number of Days To Study
Completion
Collected at CRF.
TIMEDIAG num Time To Diagnosis In Months Collected at CRF.
TRTMENT num Treatment Code Collected at CRF.
VDY num Relative Visit Day In Demo Dataset If VDATE and REF.DATE not missing then perform
below logic to calculate VDY, If VDATE less than
REF.DATE then (VDATE - REF.DATE). Else if VDATE
is greater than equal to REF.DATE then (VDATE- REF.DATE) +1.
STATUSDY num Relative Completion Status Day If STATUSDT and REF.DATE not missing then
perform below logic to calculate STATUSDY, If
STATUSDT less than REF.DATE then (STATUSDT -
REF.DATE). Else if STATUSDT is greater than equal to REF.DATE then (STATUSDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 120 | 155
Variable Type Label Codes Comments
DEATHDY num Relative Day of Death If DEATHDT and REF.DATE not missing then
perform below logic to calculate DEATHDY, If
DEATHDT less than REF.DATE then (DEATHDT -
REF.DATE). Else if DEATHDT is greater than equal to REF.DATE then (DEATHDT- REF.DATE) +1.
LEPODY num Relative Day of Last Study Dose If LEPODT and REF.DATE not missing then perform
below logic to calculate LEPODY, If LEPODT less
than REF.DATE then (LEPODT - REF.DATE). Else if
LEPODT is greater than equal to REF.DATE then (LEPODT- REF.DATE) +1.
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
DBENDDY num Relative Last Day of Double-Blind
Phase
If DBENDDT and REF.DATE not missing then
perform below logic to calculate DBENDDY, If
DBENDDT less than REF.DATE then (DBENDDT -
REF.DATE). Else if DBENDDT is greater than equal to REF.DATE then (DBENDDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 121 | 155
Variable Type Label Codes Comments
DIAGDY num Relative Day of Diagnosis of
Malignancy
If DIAGDT and REF.DATE not missing then perform
below logic to calculate DIAGDY, If DIAGDT less
than REF.DATE then (DIAGDT - REF.DATE). Else if
DIAGDT is greater than equal to REF.DATE then (DIAGDT- REF.DATE) +1.
LCHEMDY num Relative Day of Last Chemotherapy If LCHEMDT and REF.DATE not missing then
perform below logic to calculate LCHEMDY, If
LCHEMDT less than REF.DATE then (LCHEMDT -
REF.DATE). Else if LCHEMDT is greater than equal to REF.DATE then (LCHEMDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 122 | 155
1.4.52. Profile - PROFILE
Dataset PROFILE
Creating program profile.sas
Description Profile
Unique identifier DPATNO
Sorted by DPATNO
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
missing values:
INO,COUNTRY,VDATE,BIRTHDT,SEX,RACE,RACESPEC,EPO,DTERM,STATUSDT,
DEATHDT,LEPODT,DATE,STARTDT,DBENDDT,DIAGDT,LCHEMDT,SEXF,COUNTRYF,INVNAME,SURN,FORE,OTHRSPEC
Variable Type Label Codes Comments
PNO char Protocol Number Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
CRESP num Patient's Response To
Chemotherapy
Collected at CRF.
STATUS num Completion Status Collected at CRF.
DEATH num Death Collected at CRF.
REASON num Discontinuation Reason Collected at CRF.
BASEHGT num Baseline Height Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 123 | 155
Variable Type Label Codes Comments
BASEWGT num Baseline Weight Collected at CRF.
OL num Was Patient In Open-Label Study Collected at CRF.
CHEMOTYP num Type of Chemotherapy Collected at CRF.
CHEMOTYF char Decode For Chemotyp Collected at CRF.
DIAGF num Flag For Diagdt Collected at CRF.
MDIAGNOS num Diagnosis of Malignancy Collected at CRF.
PERFPRE num Performance Score At Prestudy Collected at CRF.
PERFTERM num Performance Score At Termination Collected at CRF.
PHYSDB char Physician'S Global Assess. At Wk 12 Collected at CRF.
PHYSOL char Physician'S Global Assess. At Wk 24 Collected at CRF.
PERFCHG num Chge In Perform From Pre To Term Collected at CRF.
CHEMOYN num Did Pat Receive Chemo Dur Past 6
Mon
Collected at CRF.
PRECHEMO num Did Pat Have Chemo In Past 3 Mon Collected at CRF.
CYCLES num # of Chemo Cycles In Past 6 Mon Collected at CRF.
REGORDER num Order of Regimens Collected at CRF.
REGDESC char Treatment Collected at CRF.
TRTMENTF char Treatment Collected at CRF.
REASONF char Discontinuation Reason Collected at CRF.
PHYSDBF char Decode For Physdb Collected at CRF.
PHYSOLF char Decode For Physol Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 124 | 155
Variable Type Label Codes Comments
STATUSF char Completion Status Collected at CRF.
CRESPF char Decode For Cresp Collected at CRF.
MDIAGNOF char Decode For Mdiagnos Collected at CRF.
DCOUNTRY char De-Identify Country Group element to protect PII.
RACEF char Race Collected at CRF.
OLF char Decode For Ol Collected at CRF.
CHEMOYNF char Decode For Chemoyn (1=No,
2=Yes)
Collected at CRF.
PRECHEMF char Decode For Prechemo (1=No,
2=Yes)
Collected at CRF.
DIAGDTF char Flag For Missing Parts of Dates Collected at CRF.
COMPDAYS num Number of Days To Study
Completion
Collected at CRF.
AGE char Age in Years If age is greater than 89 then group to '90+'
otherwise AGE=AGE. Grouping will be performed based on HIPAA privacy rules.
TIMEDIAG num Time To Diagnosis In Months Collected at CRF.
AGEUNIT char Unit For Age Collected at CRF.
TRTMENT num Treatment Code Collected at CRF.
VDY num Relative Visit Day In Demo Dataset If VDATE and REF.DATE not missing then perform
below logic to calculate VDY, If VDATE less than
REF.DATE then (VDATE - REF.DATE). Else if VDATE
is greater than equal to REF.DATE then (VDATE- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 125 | 155
Variable Type Label Codes Comments
STATUSDY num Relative Completion Status Day If STATUSDT and REF.DATE not missing then
perform below logic to calculate STATUSDY, If
STATUSDT less than REF.DATE then (STATUSDT -
REF.DATE). Else if STATUSDT is greater than equal to REF.DATE then (STATUSDT- REF.DATE) +1.
DEATHDY num Relative Day of Death If DEATHDT and REF.DATE not missing then
perform below logic to calculate DEATHDY, If
DEATHDT less than REF.DATE then (DEATHDT -
REF.DATE). Else if DEATHDT is greater than equal to REF.DATE then (DEATHDT- REF.DATE) +1.
LEPODY num Relative Day of Last Study Dose If LEPODT and REF.DATE not missing then perform
below logic to calculate LEPODY, If LEPODT less
than REF.DATE then (LEPODT - REF.DATE). Else if
LEPODT is greater than equal to REF.DATE then (LEPODT- REF.DATE) +1.
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
DBENDDY num Relative Last Day of Double-Blind
Phase
If DBENDDT and REF.DATE not missing then
perform below logic to calculate DBENDDY, If
DBENDDT less than REF.DATE then (DBENDDT -
REF.DATE). Else if DBENDDT is greater than equal to REF.DATE then (DBENDDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 126 | 155
Variable Type Label Codes Comments
DIAGDY num Relative Day of Diagnosis of
Malignancy
If DIAGDT and REF.DATE not missing then perform
below logic to calculate DIAGDY, If DIAGDT less
than REF.DATE then (DIAGDT - REF.DATE). Else if
DIAGDT is greater than equal to REF.DATE then (DIAGDT- REF.DATE) +1.
LCHEMDY num Relative Day of Last Chemotherapy If LCHEMDT and REF.DATE not missing then
perform below logic to calculate LCHEMDY, If
LCHEMDT less than REF.DATE then (LCHEMDT -
REF.DATE). Else if LCHEMDT is greater than equal to REF.DATE then (LCHEMDT- REF.DATE) +1.
1.4.53. Protocol - PROTOCOL
Dataset PROTOCOL
Creating program protocol.sas
Description Protocol
Unique identifier PROTOCOL
Sorted by PROTOCOL
Notes Below listed variables will be dropped from dataset due to non significant elements: TITLE1,TITLE2
Variable Type Label Codes Comments
AGEUNIT char Unit For Age Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
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Variable Type Label Codes Comments
BLINDED char Blinded Collected at CRF.
CROSOVER char Crosover Collected at CRF.
PROTOCOL char Protocol Collected at CRF.
STDYTYPE char Stdytype Collected at CRF.
FINALDB num Finaldb Collected at CRF.
FIRSTDB num Firstdb Collected at CRF.
TOTREGI num Totregi Collected at CRF.
EVENTUNT char Eventunt Collected at CRF.
DRUG char Drug Collected at CRF.
PROJECT num Project Collected at CRF.
AVAILABL char Availabl Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 128 | 155
1.4.54. Pvalue - PVALUE
Dataset PVALUE
Creating program pvalue.sas
Description Pvalue
Unique identifier PVAL
Sorted by PVAL
Notes
Variable Type Label Codes Comments
PVAL num Pr>Chi Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 129 | 155
1.4.55. EORTC QLQ-C30 - QLQC30
Dataset QLQC30
Creating program qlqc30.sas
Description EORTC QLQ-C30
Unique identifier DPATNO,VISITNO,VDY,OBSNO
Sorted by DPATNO,VISITNO,VDY,OBSNO
Notes Below listed variables will be dropped from dataset to protect PII as per HIPAA and EMA guidelines or due to repetition of the information: INIT,INO,BIRTH,BIRTHF,VDATE
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
VDATEF num Vdatef Collected at CRF.
Q1 num Q1 Collected at CRF.
Q2 num Q2 Collected at CRF.
Q3 num Q3 Collected at CRF.
Q4 num Q4 Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 130 | 155
Variable Type Label Codes Comments
Q5 num Q5 Collected at CRF.
Q6 num Q6 Collected at CRF.
Q7 num Q7 Collected at CRF.
Q8 num Q8 Collected at CRF.
Q9 num Q9 Collected at CRF.
Q10 num Q10 Collected at CRF.
Q11 num Q11 Collected at CRF.
Q12 num Q12 Collected at CRF.
Q13 num Q13 Collected at CRF.
Q14 num Q14 Collected at CRF.
Q15 num Q15 Collected at CRF.
Q16 num Q16 Collected at CRF.
Q17 num Q17 Collected at CRF.
Q18 num Q18 Collected at CRF.
Q19 num Q19 Collected at CRF.
Q20 num Q20 Collected at CRF.
Q21 num Q21 Collected at CRF.
Q22 num Q22 Collected at CRF.
Q23 num Q23 Collected at CRF.
Q24 num Q24 Collected at CRF.
Q25 num Q25 Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 131 | 155
Variable Type Label Codes Comments
Q26 num Q26 Collected at CRF.
Q27 num Q27 Collected at CRF.
Q28 num Q28 Collected at CRF.
Q29 num Q29 Collected at CRF.
Q30 num Q30 Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
VDY num Visit Day If VDATE and REF.DATE not missing then perform
below logic to calculate VDY, If VDATE less than
REF.DATE then (VDATE - REF.DATE). Else if VDATE
is greater than equal to REF.DATE then (VDATE- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 132 | 155
1.4.56. Regi - REGI
Dataset REGI
Creating program regi.sas
Description Regi
Unique identifier DPATNO
Sorted by DPATNO
Notes
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
REGORDER num Regorder Collected at CRF.
REGDESC char Regdesc Collected at CRF.
TRTMENTF char Trtmentf Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 133 | 155
1.4.57. Smedai3 - SMEDAI3
Dataset SMEDAI3
Creating program smedai3.sas
Description Smedai3
Unique identifier DPATNO,VISITNO,WEEK,DBENDDY,SMEDDY,DOSENO
Sorted by DPATNO,VISITNO,WEEK,DBENDDY,SMEDDY,DOSENO
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information:
SDATE,DBENDDT,INVNAME,SMEDDT
Variable Type Label Codes Comments
PNO char Protocol Number Collected at CRF.
DPATNO num Patient Number Assigned for De-Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
DOSENO num Dose Number Within Week (1,2,3) Collected at CRF.
WEIGHT num Weight (Kg) Collected at CRF.
DOSE num Dose Given (U/Kg) Collected at CRF.
UNIT num Unit Measure Collected at CRF.
ML num Mls Dispensed Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 134 | 155
Variable Type Label Codes Comments
REGORDER num Order of Regimens Collected at CRF.
REGDESC char Treatment Collected at CRF.
DDOSE num Derived Dose (U/Kg) Collected at CRF.
DBENDDY num Relative Last Day of Double-Blind
Phase
If DBENDDT and REF.DATE not missing then
perform below logic to calculate DBENDDY, If
DBENDDT less than REF.DATE then (DBENDDT -
REF.DATE). Else if DBENDDT is greater than equal to REF.DATE then (DBENDDT- REF.DATE) +1.
SMEDDY num Relative Day of Med
Administration
If SMEDDT and REF.DATE not missing then
perform below logic to calculate SMEDDY, If
SMEDDT less than REF.DATE then (SMEDDT -
REF.DATE). Else if SMEDDT is greater than equal to REF.DATE then (SMEDDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 135 | 155
1.4.58. Smedbi3 - SMEDBI3
Dataset SMEDBI3
Creating program smedbi3.sas
Description Smedbi3
Unique identifier DPATNO,WEEK
Sorted by DPATNO,WEEK
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines:
INVNAME
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
WEEK num Study Week Collected at CRF.
REGORDER num Order of Regimens Collected at CRF.
REGDESC char Treatment Collected at CRF.
DOUBLE num Was Patient's Dose Doubled Collected at CRF.
WITHHELD num Was Patient's Dose Withheld Collected at CRF.
CHANGE num Was There A Change In Dosing Collected at CRF.
TOTDOSE num Total Weely Dose Collected at CRF.
DOUBLEF char Decode of Double (1=No, 2=Yes) Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 136 | 155
Variable Type Label Codes Comments
WITHHLDF char Decode of Withheld (1=No, 2=Yes) Collected at CRF.
CHANGEF char Decode of Change (1=No, 2=Yes) Collected at CRF.
1.4.59. Smedci3 - SMEDCI3
Dataset SMEDCI3
Creating program smedci3.sas
Description Smedci3
Unique identifier DPATNO,WEEK
Sorted by DPATNO,WEEK
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information:
INVNAME,STARTDT
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
WEEK num Study Week Collected at CRF.
REGORDER num Order of Regimens Collected at CRF.
REGDESC char Treatment Collected at CRF.
WEEKDOUB num Weekdoub Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 137 | 155
Variable Type Label Codes Comments
DOSENODB num Dosenodb Collected at CRF.
DTDOUB num Dtdoub Collected at CRF.
DOSENOHD num Dosenohd Collected at CRF.
WEEKHELD num Weekheld Collected at CRF.
DOUBLE num Was Patient's Dose Doubled Collected at CRF.
WITHHELD num Was Patient's Dose Withheld Collected at CRF.
DAYDOUB num Daydoub Collected at CRF.
CHANGE num Was There A Change In Dosing Collected at CRF.
TOTDOSE num Total Weely Dose Collected at CRF.
DOUBLEF char Decode of Double (1=No, 2=Yes) Collected at CRF.
WITHHLDF char Decode of Withheld (1=No, 2=Yes) Collected at CRF.
CHANGEF char Decode of Change (1=No, 2=Yes) Collected at CRF.
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 138 | 155
1.4.60. Smedci3b - SMEDCI3B
Dataset SMEDCI3B
Creating program smedci3b.sas
Description Smedci3b
Unique identifier DPATNO,WEEK
Sorted by DPATNO,WEEK
Notes Below listed variables will be dropped from dataset to protect PII as per HIPAA and EMA guidelines or due to repetition of the information or due to missing values: INVNAME,DOSENOHD,STARTDT
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
WEEK num Study Week Collected at CRF.
REGORDER num Order of Regimens Collected at CRF.
REGDESC char Treatment Collected at CRF.
WEEKDOUB num Weekdoub Collected at CRF.
DOSENODB num Dosenodb Collected at CRF.
DTDOUB num Dtdoub Collected at CRF.
WEEKHELD num Weekheld Collected at CRF.
DOUBLE num Was Patient's Dose Doubled Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 139 | 155
Variable Type Label Codes Comments
WITHHELD num Was Patient's Dose Withheld Collected at CRF.
CHANGE num Was There A Change In Dosing Collected at CRF.
TOTDOSE num Total Weely Dose Collected at CRF.
DOUBLEF char Decode of Double (1=No, 2=Yes) Collected at CRF.
WITHHLDF char Decode of Withheld (1=No, 2=Yes) Collected at CRF.
CHANGEF char Decode of Change (1=No, 2=Yes) Collected at CRF.
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 140 | 155
1.4.61. Surgery - SURGERY
Dataset SURGERY
Creating program surgery.sas
Description Surgery
Unique identifier DPATNO,DY,PROCE
Sorted by DPATNO,DY,PROCE
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to missing values:
INIT,INO,DATE,VISITNO,EVENT_ID
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
SURG num Surg Collected at CRF.
DATEF num Datef Collected at CRF.
PROCE char Proce Collected at CRF.
FINDINGS char Findings Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 141 | 155
Variable Type Label Codes Comments
DISEASE char Disease Collected at CRF.
DY num Relative Medication Start Day If DATE and REF.DATE not missing then perform
below logic to calculate DY, If DATE less than
REF.DATE then (DATE - REF.DATE). Else if DATE is
greater than equal to REF.DATE then (DATE- REF.DATE) +1.
1.4.62. Respose to Chemotherapy - TERM
Dataset TERM
Creating program term.sas
Description Respose to Chemotherapy
Unique identifier DPATNO
Sorted by DPATNO
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to
missing values:
INIT,INO,CHEMO,VDATE,EPO,DTERM,DDATE,VISITNO,EVENT_ID
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 142 | 155
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
CHEMOF num Chemof Collected at CRF.
RESPO num Respo Collected at CRF.
VDATEF num Vdatef Collected at CRF.
EPOF num Epof Collected at CRF.
TERM num Term Collected at CRF.
DTERMF num Dtermf Collected at CRF.
REASON num Reason Collected at CRF.
DIED num Died Collected at CRF.
DDATEF num Ddatef Collected at CRF.
AUTOPSY num Autopsy Collected at CRF.
CHEMODY num Relative Chemo Day If CHEMO and REF.DATE not missing then perform
below logic to calculate CHEMODY, If CHEMO less
than REF.DATE then (CHEMO - REF.DATE). Else if
CHEMO is greater than equal to REF.DATE then (CHEMO- REF.DATE) +1.
VDY num Visit Day If VDATE and REF.DATE not missing then perform
below logic to calculate VDY, If VDATE less than
REF.DATE then (VDATE - REF.DATE). Else if VDATE
is greater than equal to REF.DATE then (VDATE- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 143 | 155
Variable Type Label Codes Comments
EPODY num Epo Day If EPO and REF.DATE not missing then perform
below logic to calculate EPODY, If EPO less than
REF.DATE then (EPO - REF.DATE). Else if EPO is
greater than equal to REF.DATE then (EPO- REF.DATE) +1.
TERMDY num Term Day If DTERM and REF.DATE not missing then perform
below logic to calculate TERMDY, If DTERM less
than REF.DATE then (DTERM - REF.DATE). Else if
DTERM is greater than equal to REF.DATE then (DTERM- REF.DATE) +1.
DDY num D Date If DDATE and REF.DATE not missing then perform
below logic to calculate DDY, If DDATE less than
REF.DATE then (DDATE - REF.DATE). Else if DDATE
is greater than equal to REF.DATE then (DDATE- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 144 | 155
1.4.63. Tranai3 - TRANAI3
Dataset TRANAI3
Creating program tranai3.sas
Description Tranai3
Unique identifier DPATNO,VISITNO,BTYPE,HGB
Sorted by DPATNO,VISITNO,BTYPE,HGB
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to missing values:
BCODE,BBDATE,BDATE,DATE,STARTDT,DBENDDT,INVNAME
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
REQUIRE num Has Patient Required Any
Transfusions
Collected at CRF.
BTYPE char Type of Blood Product Transfused Collected at CRF.
UNIT num Units Given Collected at CRF.
ML num Mls Given Collected at CRF.
HGB num Hemoglobin Value Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 145 | 155
Variable Type Label Codes Comments
TRANREL num Are Hgbs Related To Trans. Within
14 Day
Collected at CRF.
HBTRIG num Hgb Recorded Immed.Prior
Transfusion
Collected at CRF.
REGORDER num Order of Regimens Collected at CRF.
REGDESC char Treatment Collected at CRF.
COMPDAYS num Number of Days To Study
Completion
Collected at CRF.
REQUIREF char Decode For Require (1=No, 2=Yes) Collected at CRF.
TRANRELF char Decode For Tranrel (1=No, 2=Yes) Collected at CRF.
BDY num Relative Blood Transfusion Day If BDATE and REF.DATE not missing then perform
below logic to calculate BDY, If BDATE less than
REF.DATE then (BDATE - REF.DATE). Else if BDATE
is greater than equal to REF.DATE then (BDATE- REF.DATE) +1.
STARTDY num Relative Medication Start Day If STARTDT and REF.DATE not missing then
perform below logic to calculate STARTDY, If
STARTDT less than REF.DATE then (STARTDT -
REF.DATE). Else if STARTDT is greater than equal to REF.DATE then (STARTDT- REF.DATE) +1.
DBENDDY num Relative Last Day of Double-Blind
Phase
If DBENDDT and REF.DATE not missing then
perform below logic to calculate DBENDDY, If
DBENDDT less than REF.DATE then (DBENDDT -
REF.DATE). Else if DBENDDT is greater than equal to REF.DATE then (DBENDDT- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 146 | 155
1.4.64. Tranbi3 - TRANBI3
Dataset TRANBI3
Creating program tranbi3.sas
Description Tranbi3
Unique identifier DPATNO
Sorted by DPATNO
Notes
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
REGORDER num Order of Regimens Collected at CRF.
REGDESC char Treatment Collected at CRF.
COMPDAYS num Number of Days To Study
Completion
Collected at CRF.
TRANSOL num Was Pat Trans During Open-Label Collected at CRF.
PRETRND num Was Pat Trans Dependent At
Prestudy
Collected at CRF.
UNITSM0 num Sum of Units Transfused Prestudy Collected at CRF.
TRANSM1 num Was Pat Trans During Month 1 Collected at CRF.
UNITSM1 num Sum of Units Trans During Month 1 Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 147 | 155
Variable Type Label Codes Comments
TRANSM2 num Was Pat Trans During Month 2 Or
3
Collected at CRF.
UNITSM2 num Sum of Units Trans During Mon 2
And 3
Collected at CRF.
UNITSOL num Sum of Units Trans During Open-
Label
Collected at CRF.
TRANSDB num Was Pat Trans During Db Phase Collected at CRF.
DAYSM1 num # of Days On Study During Month 1 Collected at CRF.
DAYSM2 num # of Days On Study During Month 2 And 3
Collected at CRF.
CUMTRNM2 num Cumul. Trans. Rate During Mon 2
And 3
Collected at CRF.
HBTRIG0 num Pre-Study Pre-Transusion Hgb Collected at CRF.
HBTRIG1 num During Db Pre-Transusion Hgb Collected at CRF.
TRANSDBF char Decode For Transdb (1=No, 2=Yes) Collected at CRF.
PRETRNDF char Decode For Pretrnd (1=No, 2=Yes) Collected at CRF.
TRANSOLF char Decode For Transol (1=No, 2=Yes) Collected at CRF.
TRANSM1F char Decode For Transm1 (1=No, 2=Yes) Collected at CRF.
TRANSM2F char Decode For Transm2 (1=No, 2=Yes) Collected at CRF.
TRANM2P num Transm2=Yes Or Study Days <=28 Collected at CRF.
TRANM2PF char Decode For Transm2P (1=No,
2=Yes)
Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 148 | 155
1.4.65. Tranci3 - TRANCI3
Variable Type Label Codes Comments
DPATNO num Patient Number Assigned for
De-Identity
Randomly assigned Patient Number for De-Identity
REGORDER num Order of Regimens Collected at CRF.
REGDESC char Treatment Collected at CRF.
COMPDAYS num Number of Days To Study
Completion
Collected at CRF.
TRANSOL num Was Pat Trans During Open-
Label
Collected at CRF.
PRETRND num Was Pat Trans Dependent At
Prestudy
Collected at CRF.
UNITSM0 num Sum of Units Transfused
Prestudy
Collected at CRF.
Dataset TRANCI3
Creating program tranci3.sas
Description Tranci3
Unique identifier DPATNO
Sorted by DPATNO
Notes Below listed variables will be dropped from dataset due to repetition of the
information:
DATE56,DATE28
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 149 | 155
Variable Type Label Codes Comments
TRANSM1 num Was Pat Trans During Month 1 Collected at CRF.
UNITSM1 num Sum of Units Trans During
Month 1
Collected at CRF.
TRANSM2 num Was Pat Trans During Month 2
Or 3
Collected at CRF.
UNITSM2 num Sum of Units Trans During
Mon 2 And 3
Collected at CRF.
TRANSM3 num Was Pat Trans During Month 3 Collected at CRF.
UNITSM3 num Unitsm3 Collected at CRF.
UNITSOL num Sum of Units Trans During
Open-Label
Collected at CRF.
TRANSDB num Was Pat Trans During Db
Phase
Collected at CRF.
DAYSM1 num # of Days On Study During
Month 1
Collected at CRF.
DAYSM2 num # of Days On Study During
Month 2 And 3
Collected at CRF.
CUMTRNM2 num Cumul. Trans. Rate During
Mon 2 And 3
Collected at CRF.
HBTRIG0 num Pre-Study Pre-Transusion Hgb Collected at CRF.
HBTRIG1 num During Db Pre-Transusion Hgb Collected at CRF.
TRANSDBF char Decode For Transdb (1=No,
2=Yes)
Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 150 | 155
Variable Type Label Codes Comments
PRETRNDF char Decode For Pretrnd (1=No,
2=Yes)
Collected at CRF.
TRANSOLF char Decode For Transol (1=No,
2=Yes)
Collected at CRF.
TRANSM1F char Decode For Transm1 (1=No,
2=Yes)
Collected at CRF.
TRANSM2F char Decode For Transm2 (1=No,
2=Yes)
Collected at CRF.
TRANSM3F char Decode For Transm3 (1=No,
2=Yes)
Collected at CRF.
TRANM2P num Transm2=Yes Or Study Days
<=28
Collected at CRF.
TRANM2PF char Decode For Transm2P (1=No,
2=Yes)
Collected at CRF.
_56DY num Relative Day of 2 Months After
Stdy Day
If DATE56 and REF.DATE not missing then perform
below logic to calculate _56DY, If DATE56 less than
REF.DATE then (DATE56 - REF.DATE). Else if DATE56
is greater than equal to REF.DATE then (DATE56- REF.DATE) +1.
_28DY num Relative Day of 1 Month After Study Day
If DATE28 and REF.DATE not missing then perform
below logic to calculate _28DY, If DATE28 less than
REF.DATE then (DATE28 - REF.DATE). Else if DATE28
is greater than equal to REF.DATE then (DATE28- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 151 | 155
1.4.66. Transfusion Information - TRANS_SI
Dataset TRANS_SI
Creating program trans_si.sas
Description Transfusion Information
Unique identifier DPATNO,VISITNO,OBSNO
Sorted by DPATNO,VISITNO,OBSNO
Notes Below listed variables will be dropped from dataset to protect PII as per
HIPAA and EMA guidelines or due to repetition of the information or due to missing values:
INIT,INO,CODE,DATE
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
TRANS num Trans Collected at CRF.
TYPE char Type Collected at CRF.
DATEF num Datef Collected at CRF.
UNIT num Unit Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 152 | 155
Variable Type Label Codes Comments
MLS num Mls Collected at CRF.
H103 num H103 Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.
DY num Relative Medication Start Day If DATE and REF.DATE not missing then perform
below logic to calculate DY, If DATE less than
REF.DATE then (DATE - REF.DATE). Else if DATE is
greater than equal to REF.DATE then (DATE- REF.DATE) +1.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 153 | 155
1.4.67. Tve - TVE
Dataset TVE
Creating program tve.sas
Description Tve
Unique identifier BODYSYS,PREF_TRM,TVENO,ADVCODE
Sorted by BODYSYS,PREF_TRM,TVENO,ADVCODE
Notes Below listed variables will be dropped from dataset due to non significant
elements:
ADVDESC
Variable Type Label Codes Comments
TVENO num Tveno Collected at CRF.
ADVCODE char Who Included Code Collected at CRF.
SEXAE char Sex Specific AE Collected at CRF.
BODYSYS char Body System Collected at CRF.
PREF_TRM char Who Preferred Term Description Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 154 | 155
1.4.68. Urinalysis (Test Tape) - URIN_SI
Dataset URIN_SI
Creating program urin_si.sas
Description Urinalysis (Test Tape)
Unique identifier DPATNO,VISITNO
Sorted by DPATNO,VISITNO
Notes Below listed variables will be dropped from dataset to protect PII as
per HIPAA and EMA guidelines:
INIT,INO
Variable Type Label Codes Comments
OBSNO num Obsno Collected at CRF.
STUDY char Study Collected at CRF.
DPATNO num Patient Number Assigned for De-
Identity
Randomly assigned Patient Number for de-identity
VISITNO num Visit Number Collected at CRF.
WEEK num Study Week Collected at CRF.
URIN num Urin Collected at CRF.
URINF num Urinf Collected at CRF.
U307 char U307 Collected at CRF.
U348 char U348 Collected at CRF.
Anonymisation Data Derivation Specification EPO_INT3
C O N F I D E N T I A L P a g e 155 | 155
Variable Type Label Codes Comments
U306 char U306 Collected at CRF.
U309 char U309 Collected at CRF.
U316 char U316 Collected at CRF.
U315 char U315 Collected at CRF.
U320 char U320 Collected at CRF.
U314 char U314 Collected at CRF.
CU319 char Cu319 Collected at CRF.
U319 char U319 Collected at CRF.
U303 num U303 Collected at CRF.
U304 num U304 Collected at CRF.
EVENT_ID char Event_Id Collected at CRF.